Dexacell s the addition of oral dexamethasone to usual care in patients who present to urgent and emergency care with cellulitis effective and cost-effective in terms of reducing pain, improving quality of life, and reducing further antibiotic usage and healthcare use?

Why is this an important question to answer?
Cellulitis is a common bacterial skin infection and has a major impact on patients and healthcare utilisation. Hospital treatment costs in England and Wales alone are estimated at £220 million per year (1). When patients with cellulitis attend hospital they are usually treated with antibiotics and painkillers (2). However, even with this treatment around 1 in 5 patients will later seek further treatment due to ongoing symptoms – most often this is due to pain. This can lead to additional doctors appointments, A&E visits and additional antibiotics (3). It is therefore important to look for other ways to reduce early symptoms in patients with cellulitis, particularly pain.

There is a type of anti-inflammatory medicine called ‘corticosteroids’ that are often given to reduce inflammation and pain, improving short-term symptoms in patients with other types of infection and many other conditions. They are not currently used for the treatment of cellulitis but small research studies suggest that the addition of oral corticosteroids to antibiotics reduces pain and other symptoms, without adverse effects (4-6). Because of this, some guideline bodies recommend corticosteroids in patients with cellulitis, while others suggest further trial data is needed. A definitive clinical trial is needed to establish the costs and benefits of giving corticosteroids to patients with cellulitis by assessing outcomes that matter to patients and the health service.

We are therefore running this large trial across multiple hospitals across England and Wales. We are aiming to recruit 450 patients to participate in the trial so that we can find out whether giving people with cellulitis a ‘corticosteroid’ called dexamethasone can:

• Reduce pain,
• Improve quality of life,
• Reduce additional healthcare appointments,
• Reduce the need for extra antibiotics and pain relief,
• Reduce costs.

PI: Dr Edd Carlton

Planned end date: 31st January 2026

Local ref: 5411

Our aim is to understand how best to investigate acute severe headaches, which are suggestive of a condition called subarachnoid haemorrhage (SAH). SAH is a potentially severe cause of headache in the UK and requires urgent identification and treatment. It is defined as the presence of blood within one of the layers of the brain. At its most serious, it can cause death and severe disability.

We want to understand the accuracy of CT brain scanning in the Emergency Department (ED) and how this accuracy changes with time.

We will collect data on patients presenting to the Emergency department that have headaches reaching peak intensity within one hour. These are the classic headache patterns that raise concern with clinicians about the possibility of SAH. We will use this data to try and validate recently proposed clinical rules, and CT brain strategies, which suggest they can exclude the possibility of SAH with a high degree of precision.

With this information, we will be able to inform clinicians how accurate CT brain scans are safely excluding SAH. Further to this, we will highlight how this accuracy changes depending on the timing of the scan, using hourly intervals from onset of the headache. We will also evaluate the accuracy of clinical decision rules (without any brain scans) to exclude the condition of SAH.

Project Details
Principal Investigator: TBC
Planned End Date: TBC
Local Ref: 4761

MUUTO Delphi Study: Establishing Best Practice in Managing Malignant Upper Urinary Tract Obstruction

The Bristol Urological Institute, in partnership with North Bristol NHS Trust, is leading a national Delphi consensus study to develop best practice standards for the management of Malignant Upper Urinary Tract Obstruction (MUUTO)—a complex condition affecting patients with advanced cancers.

MUUTO can lead to significant symptoms, infection risk, and impaired kidney function, yet currently there is no national guidance to inform treatment decisions. Management varies widely across the UK, often leaving clinicians and patients without clear direction—particularly in emergency settings. This study brings together around 40 expert clinicians from across urology, oncology, interventional radiology, palliative care, and specialist nursing. Using the Delphi method, which is an established process for building expert consensus, the study will run two survey rounds followed by a final discussion meeting to agree on clinical standards. Importantly, this work has been shaped by patients and carers. Prior research revealed many felt confused about their diagnosis and excluded from decision-making. Their insights have helped define the focus of this study, ensuring the guidance developed reflects real patient needs.

The final output will be a set of practical, consensus-based recommendations to guide MUUTO diagnosis, intervention decisions (e.g. stents or nephrostomy), and palliative care options. These will support clinicians in delivering more consistent, evidence-informed, and patient-centred care. The study is scheduled to run over six months in 2025. Results will be shared via peer-reviewed publications, professional networks, and national conferences.

For Participant information, please visit here.

Project Details:

Principal Investigator: Mr Jonathan Aning
Local Ref: 5775

ACCTUATE is a randomised control trial, comparing the newly designed CymActive catheter, with a standard Foley type, over a period of three months. 

The Foley catheter was designed in the 1930’s, and is still in common use today, despite having several major side effects, including high levels of infection and impaired quality of life. The ACCTUATE study seeks to establish the acceptability of a newly designed catheter, the CymActive. The Cymactive catheter differs from the foley in design and use. It is entirely indwelling, and activated using a magnet, rather than having tubes protruding from the body, and is anchored in place with a mallecot anchoring system rather than the standard water filled balloon used by the foley, allowing complete bladder emptying. 

The primary aim of this study is to measure patients quality of life and pain, using patient questionnaires. The study will also monitor adverse events, and compare urine samples from the beginning and end of the study. 

For this study we are recruiting men with long term foley catheters, no previous lower urinary tract surgeries, with non-neurogenic urinary retention, of any age. 

Project Details

Principle Investigator: Professor Hashim Hashim. 

Planned recruitment end date: October 2025

Local reference: 5516

Prospective, non-randomized, multicentre clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)

Sacral Neuromodulation (SNM) is a recommended treatment for Overactive Bladder (OAB) including urinary urgency incontinence (UUI) and urinary frequency (UF), and fecal incontinence (FI). Long-term data support the safety, efficacy, and durability of the therapy. 

This study is a multi-centre non randomized, single arm trial, aiming to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. 

INS Model 4101, also known as F15 is a non-rechargeable system, whereas previous Axonics neurostimulators use a rechargeable battery source that requires monthly recharging by the patient. The mechanism of action is identical to previous devices: therapy is delivered to the sacral nerve, typically the 3rd sacral nerve root. Model 4101 (F15) uses the same exact stimulation waveform as the previous Axonics models.

For this study, patients who are listed for SNM at Southmead, for OAB, will be offered the opportunity to participate, and followed up for a year after implantation, attending 3 monthly check ups and completing a series of questionnaires. 

Project Details

Principle Investigator: Professor Hashim Hashim

Planned recruitment end date: July 2025

Local Reference: 5668

A comparison of diagnostic accuracy of Luminal Index and Standard of Care MRI for Accelerated detection of significant prostate cancer 

This study is trying to establish if a scanning method called Luminal Index MRI (LI-MRI) might be able to be as good as the Standard of Care MRI (SOC-MRI). 

A LI-MRI scan takes only 5-10 minutes compared to up to 45 minutes needed for a SOC-MRI scan and it does not require the injection of dye to improve images. 

Most people that enter the study will have had a PSA (Prostate Specific Antigen) blood test with a higher-than-normal reading.

Routinely, the next step would be to have a SOC-MRI scan of the prostate to investigate. 

Participants to the trial will have both types of MRI, the usual SOC-MRI plus the new LI-MRI in the same scan session.

The purpose of the MRI is to produce an image that your doctor examines to look for anything of concern that needs to be investigated further. 

If there is, the doctor would usually take samples of prostate tissue (biopsies) using a needle that would then be examined under a microscope to see if what was seen on the MRI image was cancer or caused by something else. 

Project Details

Principal Investigator: Mr Douglas Kopcke and Mr Stefanos Bolomytis (Co-PI)

Planned Recruitment End Date: Summer 2026

Local Ref: 5598

A radical prostatectomy (surgical treatment for prostate cancer) involves removal of the entire prostate gland and, in some cases, removal of the nearby pelvic lymph nodes.

 Even though both types of surgery take place in the UK, we do not know which one is better for men.  About 30% of men in the UK have some lymph nodes removed during their surgery for prostate cancer and the rest do not. Your surgeon will always use their expertise to decide what treatment is best for you. In this situation they are unsure whether it is best to leave the lymph nodes in or to take them out. 

The ELIPSE study will help us find out which is the best treatment for men who need to have prostate cancer surgery in future.  The ELIPSE study aims to answer the question, 'In men having surgery for prostate cancer, is removing lymph nodes better than not removing them?' 

Participants will be randomly allocated to one of two groups: prostatectomy alone or prostatectomy plus lymph node dissection, then followed up with questionnaires and medical records review.

Project Details:

Principal Investigator: Mr Anthony Koupparis

Planned Recruitment End Date: August 2026

Local Ref: 5212

MoonRISe-1 is a clinical research study of an investigational drug delivery system for adults with intermediate-risk non-muscle invasive bladder cancer.

The MoonRISe-1 study is evaluating an investigational drug delivery system called TAR-210.

Study doctors want to learn more about the effects of TAR-210 when it delivers controlled doses of an investigational medication (erdafitinib) into the bladder over approximately 12 weeks.

The TAR-210 is a small, flexible tube that is inserted into the bladder by a healthcare professional using a urinary catheter.

TAR-210 is not approved for use by any regulatory authority and can only be used in research studies such as this one.

Suitability for this trial includes testing your bladder tumour for specific genetic alterations called fibroblast growth factor receptor (FGFR) alterations.

FGFR alterations can be a factor in tumour growth and whether the cancer spreads.

FGFR testing needs to be performed on a urine and/or tumour tissue sample collected at screening.

If your tumour has the required FGFR alterations, you may be eligible to participate in the MoonRISe-1 study.

If you are eligible for this study, you will be randomly assigned to either :

Group A: The investigational drug delivery system (TAR-210) OR:

Standard of Care Chemotherapy (intravesical Mitomycin C)

Project Details

Principal Investigator: Miss Helena Burden

Planned Recruitment End Date: Summer 2025 

Local Ref: 5531

Early stage prostate cancer can be managed by active surveillance, where patients are closely monitored. If the cancer reaches a certain stage (“progresses”) the patient can access curative treatment (such as surgery or radiotherapy). In the TAPS02 trial we are testing to see if we can slow down this chance of progression or maybe even stop it using short-term drug treatment.

The drug used is Apalutamide. It belongs to a group of drugs that work by blocking androgens (male hormones). By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing. Doctors currently use apalutamide to treat men with non-metastatic castration-resistant prostate cancer (prostate cancer for which initial treatments have failed).

In the TAPS02 trial we are testing if short-term apalutamide might slow tumour growth and make it less likely for men on surveillance to progress and need treatment. Eligible participants are randomly selected to receive apalutamide or placebo and followed up accordingly with blood tests, health checks and imaging.

Project Details

Principal Investigator: Mr Jonathan Aning

Planned Recruitment End Date: Spring 2026

Local Ref: 5543

Background

Pelvic health or pelvic floor symptoms during pregnancy or after childbirth are more common than often recognised. Research evidence suggests that about one in three women will experience some form of urinary incontinence after childbirth, one in ten faecal incontinence, and one in 12 pelvic organ prolapse. More than two-thirds of women with postpartum urinary incontinence and more than a third of women with faecal incontinence will still report it 12 years later. Several studies suggest that pelvic floor dysfunction is significantly under-reported due to embarrassment, self-consciousness, or a belief that it is ‘normal’ after pregnancy. The impact on women’s lives can be devastating, affecting affect women’s ability to work, their sexual and social relationships, and post-natal mental health.

What is the aim?

To develop a new questionnaire to help identify symptoms that affect pelvic health during pregnancy or postpartum. This is to empower women to self-report and monitor symptoms affecting the bladder, bowel and vagina, such as incontinence, and prolapse issues.

Asking women to routinely complete this questionnaire at key times during pregnancy is expected to raise awareness and identification of these symptoms, and improve referrals to specialist services for treatment when needed.

What will the PPHSAT project do?

The questionnaire will be developed according to a rigorous process, involving consultations with women and healthcare professionals, before being quantitatively tested in the maternity pathway.

There will be three main sub-studies:

• Exploratory interviews with perinatal women to understand their experiences of pelvic health issues, and expectations of care. This is alongside consultations with healthcare professionals and the public, to understand their views on what the content of the tool should be.
• Interviews with perinatal women to user test and refine the resulting tool.
• Quantitative testing of the final tool to understand how well it performs in practice in the maternity pathway

How is the study funded?

This study is funded by NHS England & Improvement as part of the national Maternity Transformation programme.

Project Details

Co-chief investigator: Dr Alan Uren, North Bristol NHS Trust

Co-chief investigator: Prof Nikki Cotterill, University of the West of England

Planned end date: 20/03/2024

Outcomes in patients with high-risk prostate cancer who undergo radical prostatectomy (surgery which aims to remove the whole prostate, and the cancer cells inside it) as a primary therapy have not significantly improved with time. Early prostate cancer is highly responsive to hormonal blockade. Therefore, androgen (a steroid hormone) blockade prior to and after prostate surgery could decrease tumour burden, increase the likelihood of complete resection and improve objective outcomes such as metastasis-free survival (MFS – time without the cancer spreading) and overall survival (OS).

The purpose of this study is to determine whether 6 months of treatment with apalutamide (an antagonist of the androgen receptor), with or without abiraterone acetate and prednisone (AAP), and in combination with androgen deprivation therapy (ADT), improves the pathological complete response rate and MFS rates in patients with high risk localised prostate cancer that are indicated to undergo a radical prostatectomy, compared to patients receiving ADT and a placebo.

The study will consist of a screening period of up to 35 days, after which participants will be randomised (randomly selected) to receive either apalutamide (with or without AAP) and ADT or receive ADT and a placebo. Participants will then receive 6 months of treatment in 28 day treatment cycles, before undergoing a radical prostatectomy. They will then receive a further 6 months of treatment. Following the treatment phase, participants will enter a post treatment phase in which they will be followed up until death, the cancer spreads, they withdraw from the study or they are lost to follow-up.

Project Details
Principal Investigator: Mr Jonathan Aning
Planned End Date: 02/05/2023
Local Ref: 4398

End-stage kidney disease (ESKD) affects ~55,000 people in the UK, with ~7,000 newly affected people each year. It ranks among the most severe of the chronic non-communicable diseases. Morbidity is high, with dialysis patients in the UK admitted to hospital on average ~1.5-2.0 times per year and spending ~15 days in hospital per year. Quality of life on dialysis is also well below that of the general population. There is therefore an unmet and urgent need to improve ESKD patient treatment.

Renal replacement therapy (dialysis or transplantation) is necessary when patients become symptomatic of ESKD. Currently ~90% of dialysis patients are on some form of haemodialysis (HD) or haemodiafiltration (HDF). Although HD and HDF can be performed at home, the majority is performed in-centre.

Treating the 25,000 people on HD costs around £500m of NHS spending each year, with a further £75m spent on hospital admissions and £50m on transport to and from dialysis. Half of patients now starting dialysis are 65 years or older and less likely to be fit for kidney transplantation and in the general population this group is predicted to increase by 60% (from 10.3m to 16.9m) by 2035. While preventing ESKD in the first place should remain a priority, the optimal form of dialysis will remain highly relevant to the NHS.

This study aims to establish the effectiveness and cost-effectiveness of high-volume HDF compared with high-flux HD in adult patients with ESKD on maintenance thrice weekly in-centre HD. We will do this by running a randomised controlled trial using non-cancer mortality or hospital admission due a cardiovascular event or infection as our primary outcome.

For more information about this study, please visit the H4RT website.

Project Details
Principal Investigator: Dr Fergus Caskey
Planned End Date: 30/09/2025
Local Ref: 3859

When kidney function drops to 15% of normal, symptoms such as tiredness, loss of appetite and sickness usually develop. At this stage, dialysis or kidney transplantation is considered. Not all patients are suitable for a kidney transplant so the following treatment options may be being considered:

• To prepare for renal dialysis if things progress – this involves visiting the hospital for 4 hours of treatment 3 times a week, or flushing fluid in and out of the body through the abdomen 4 times a day every day at home.
• To have all supportive treatment and care, but not plan to start renal dialysis even if things progress – this focuses on controlling symptoms with medication and aims to minimise hospital clinic visits and admissions. 

Surprisingly, for people over 65 with other health problems, survival and quality of life seem to be similar with these options. As a result, doctors and nurses seem to give quite different advice to their patients and the treatment people choose depends a lot on which renal unit they attend. More evidence is needed, therefore, to help patients and their families make an informed decision about the right treatment for them.

 The Prepare study is a randomised controlled trial which aims to provide far better evidence to help patients and their families reach the best decision for them and influence NHS policy on care for this group of patients.

For more information about this study, please visit the Prepare for Kidney Care website.

Project Details
Principal Investigator: Dr Fergus Caskey
Planned Recruitment End Date: May 2024
Report findings to NIHR August 2025

Local Ref: 3858a

Vitamin D deficiency is common in kidney failure and is a strong predictor of death from cardiovascular disease, infections and cancer. Dialysis patients typically receive pre-activated vitamin D, since it used to be thought that only the kidneys activate vitamin D. However, this increases blood calcium concentrations and may paradoxically make vitamin D deficiency worse. International treatment guidelines now recommend that kidney patients receive inactive vitamin D (known as cholecalciferol), since we now know that every organ activates vitamin D as required, even in kidney failure. However, this approach has not yet been tested in a trial. We will test whether supplementation with cholecalciferol increases survival in UK dialysis patients.

We will randomly assign adult UK dialysis patients to cholecalciferol or standard care.

We will determine the number of deaths over time in the two groups, to establish whether cholecalciferol improves survival. Whether patients are alive or dead at the end of the study will be determined from the national deaths register. We will also measure any differences in survival free from cardiovascular events, infections and cancers, the three leading causes of death in those on dialysis. We will use questionnaires to compare the quality of life of those in the two groups.

Currently only 68% of patients survive 3 years or more on dialysis. Assuming that this will be the case in the control group, we would need to witness 2200 deaths during the study to determine with a sufficient degree of certainty whether cholecalciferol improves survival. We estimate that this would require the inclusion of 4200 patients, followed for a total study duration of approximately 7 years. Put differently, this trial is designed to detect whether cholecalciferol has a clinically relevant effect by saving 4 or more lives for every 100 patients treated.

Project Details
Principal Investigator: Dr James Bushnell
Planned End Date: 01/03/2023
Local Ref: 4021

A study to correlate the epidemiological and clinical features of Steroid Resistance Nephrotic Syndrome including FSGS (Focal Segmental GlomeruloSclerosis) in childhood and Adulthood, in the UK, with genotype and to develop biomarkers of disease activity post-transplant.

Project Details
Principal Investigator: Dr Simon Satchell
Planned End Date: 31/12/2021
Local Ref: 2854

The National Registry of Rare Kidney Diseases (RaDaR) is a research initiative by UK kidney specialists (the Renal Association and the UK Renal Registry). It is designed to gather information from patients who have rare kidney diseases. This will give a much better understanding of how these illnesses affect people. It will help to improve treatment and identify possible causes of these rare diseases.

As patient information is entered into the database, researchers will be able to analyse whether certain aspects of their condition (e.g. laboratory results or treatments) are associated with specific benefits or complications. By allowing the research team to link this data with that gathered from other clinical studies, researchers will also be able to study the long-term outcome of these rare conditions and any treatments they may receive.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 09/10/2024
Local Ref: 2962

Primary systemic vasculitidies (PSV), encompassing Anti-Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis and medium vessel vasculitis, are relatively uncommon diseases, but have a propensity for renal involvement and account for a significant number of patients with both acute and chronic kidney disease. The aetiology of PSV is unknown and current therapies are non-specific and associated with major side effects. Outcome data for such patients have comprised small cohort studies from single centres. Understanding the factors that influence disease outcome and the impact different therapies have outside of clinical trials can only be achieved using a larger number of patients, accrued from multiple different units.

We propose to establish the first pan-UK PSV dataset, which will collect regular returns regarding patient recruitment and outcome from all participating centres. This will facilitate investigation of disease associations, outcomes and demographic trends for the UK PSV population. We will test the hypothesis that disease incidence is increasing in Indo-Asians and why the outcome may be different among different ethnic groups, as well as investigating contemporary outcomes with modern immunosuppressive protocols. In addition, we will combine clinical phenotype with genetic studies. Specifically we will investigate genetic variation between ethnic groups by looking at variations in DNA sequences that can help to explain differences in disease susceptibility. These are investigated using many DNA specific markers, called single-nucleotide polymorphisms (SNPs) whose expression will be compared between patients from different ethnic groups.

Finally, we will be able to record the outcome of all patients treated with novel therapeutics, thus eliminating the significant reporting bias that exists. This will allow individual investigators to carry out particular projects mining the dataset.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 28/02/2022
Local Ref: 3724

Calciphylaxis is a rare condition which results in small arteries becoming calcified. This results in painful ulceration of the skin which in turn can result in infection and further damage to tissue. It is associated with a high mortality rate (60–80%).

Consequently, research into this area is important. The aims of this study are to determine the following:

• What is the natural history of the disease?
• What risk factors are associated with development and progression of calciphylaxis?
• Which treatments currently in clinical practice confer a favourable outcome?
• What are the underlying disease processes?

These aims will be achieved by collecting information on medications, clinical parameters, local laboratory tests, measuring specific proteins and molecules in blood and tissue as well as studying patient’s DNA profiles.

Project Details
Principal Investigator: Mrs Saira Risdale
Planned End Date: 01/09/2021
Local Ref: 2970

This application relates to Phase 2 of the UNPACK study. Phase 1 - a qualitative interview study - informed Phase 2: a discrete choice experiment. Phase 2 uses the same screening and recruitment processes as in Phase 1. This application covers piloting of the study at a single site. It is our intention to expand to more sites following an amendment. This application will be submitted to the Research Ethics Committee that reviewed Phase 1.

Individuals at risk of kidney failure must choose between transplantation, dialysis, and non-dialysis care (also known as ‘comprehensive conservative care’ - CCC). Older people are rarely medically suitable for transplantation and are more likely to choose CCC than younger people. This may be because they don’t want intrusive treatment and are willing to live shorter lives to avoid it. Dialysis is particularly burdensome for them, with marginal survival benefit. People close to them, such as family members, are also involved in decision-making, but may be less willing to consider reduced survival to avoid treatment burden.

The trade-offs that older UK patients and those close to them are prepared to make have never before been quantified. Phase 1 of the UNPACK study used qualitative interviews to identify they treatment attributes and outcomes important to older people with kidney disease and those close to them when deciding between dialysis or CCC.

The discrete choice experiment is a questionnaire based on hypothetical treatment scenarios that measures treatment preferences of older people at risk of kidney failure and those close to them. The process will quantify and compare the importance of the treatment attributes (location and frequency) and outcomes (quality and quantity of life) identified in Phase 1. The results of this process will be used to inform the development of kidney services that fit better with the preferences of individuals using them.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31/10/2022
Local Ref: 4764

Researchers want to find out if the drug bardoxolone methyl can improve the disease ADPKD (autosomal dominant polycystic kidney disease).

Bardoxolone methyl is an investigational (experimental) drug that is being tested and is currently not approved by any regulatory agency for sale. It is a semi-synthetic (man-made) substance based on the scaffold of the natural product oleanolic acid. Bardoxolone methyl was shown to inhibit inflammation-mediated processes and to improve parameters of kidney function in multiple clinical studies.

In this study, bardoxolone methyl will be given to participants as a capsule (pill).

The study has two main purposes:

• To see if bardoxolone methyl pills are safe and well tolerated in patients with ADPKD
• To see if bardoxolone methyl pills improve the estimated glomerular filtration rate (eGFR), a measure of kidney function

The study plans to enrol approximately 300 patients with ADPKD who are between the age of 18 and 70 years at up to 100 global study centres.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31/12/2021
Local Ref: 4870

The ALIGN clinical trial is looking into a new tablet and it’s effectiveness in treating IgA Nephropathy, a disease which affects the tiny filters in the kidneys and their ability to remove ‘waste’ from the body which can lead to End Stage Kidney Disease and the need for Dialysis. Atrasentan has been developed by Chinook Therapeutics and has previously shown positive results in over 5000 people with diabetic kidney disease. In this study the tablet is taken once a day for 2.5 years. The trial is placebo-controlled meaning there is a 50/50 chance of receiving the trial drug or an inactive placebo, and to reduce bias, neither participants or their Doctors will know which they receive. 

A dedicated study team of nurses and doctors will care for participants during their time on the study, in partnership with their usual kidney doctors, and will see the participants in clinic approx. every 12 weeks, after a few weekly visits initially.

IgA Nephropathy currently has no approved treatments other than generic blood-pressure control and doctors are excited about the prospect of a treatment to delay the progression of this disease.

Principal Investigator: Dr Albert Power

Planned End Date: March 2023

Internal Reference: 5160

Individuals on dialysis are at risk of developing heart problems such as heart attacks and heart failure as well as high blood pressure. There is an urgent need for treatments that reduce the risk of heart problems in patients that require dialysis. Spironolactone is a tablet that is approved in the UK and has been used for over 50 years to treat heart problems in patients that do not require dialysis. Spironolactone belongs to a class of medicines called mineralocorticoid receptor antagonists (MRAs) and works by blocking a hormone called aldosterone in the body that can damage the heart.

Although spironolactone is very effective in patients that do not require dialysis, it is not known if spironolactone is effective in dialysis patients. We hope that this study will help determine if spironolactone works in dialysis patients. The purpose of this study is to determine if taking spironolactone will reduce death or hospitalization for heart failure and to see if it is well tolerated in patients that require dialysis.

Eligible participants will be asked to take spironolactone for 7-14 weeks to make sure it is safe for them. This is done by checking potassium results on weeks 1,2,3 and 7.  In the next part of the study, the participant will either be assigned to take the spironolactone tablet or a placebo (a tablet with no active medication) once a day.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31 Dec 2023
Local Ref: 4891

There is a great shortage of kidneys for transplantation. All kidneys from deceased donors carry risk to the recipient (risk of not working, or of disease transmission), but donor age is strongly associated with poor function and early failure of the kidney transplant. This is important, because the majority of the pool of potential UK deceased donors are now over 60 years old. Thus, if we can improve our identification of kidneys from older donors that are better ‘quality’, we can maximise numbers of transplants performed without compromising transplant outcomes.

The use of urgent kidney biopsy (analysis of a small portion under the microscope) to identify age-related damage has been reported to aid selection of those kidneys from older donors that are good enough ‘quality’ for transplantation. This approach has not been widely adopted in the UK, because the exact impact that the extra information provided by biopsy has on transplant numbers and on transplant outcomes is not clear, and its cost effectiveness remains unproven.

Our study will evaluate whether providing an urgent 24 hour National Biopsy Service increases the number and function of kidneys transplanted from donors aged over 60 years. The study is a national trial: every four months a randomly-chosen group of UK kidney transplant centres will be offered access to the National Biopsy Service (a ‘stepped-wedge cluster randomised trial’). By the end of the trial, all UK centres will have access, and we will then compare results for each centre from before and after the biopsy service was made available as well as evaluating the cost of providing the service. We anticipate that this comparison will show that biopsy availability increases the use of kidneys from elderly donors by about 10%, which equates to an additional 180 kidney transplants performed in the UK per year.

Project Details
Principal Investigator: Dr Samuel Turner
Planned End Date: 31/01/2022
Local Ref: 4119