NBT Researcher

Renal Current Research

North Bristol NHS Trust is a centre of excellence for the delivery of care for people with renal impairment. We are also home to the main kidney transplant centre in the South West.

Our experienced research team works collaboratively with a number of other research teams including diabetes and cancer to deliver cross-functional complex studies in addition to studies focused solely within the renal service.

Please speak to the person treating you to find out if there is a research study that may be able to help you.

Current Studies:

H4RT

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: 31/03/2024
Local Ref: 3859

RCT PrepareME for Kidney Care

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 End Date: 31/12/2023
Local Ref: 3858a

Cholecalciferol in Patients on Dialysis - SIMPLIFIED

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

NephroS: The National Study of Nephrotic Syndrome (NURTuRE)

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

RaDaR

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

UKIVas

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

Otsuka: JINARC PASS

This is a multicentre, prospective, non-interventional study to assess the long-term safety profile of JINARC when prescribed to patients for Autosomal Dominant Polycystic Kidney Disease (ADPKD).

JINARC (tolvaptan) is currently the only treatment option for slowing the progression of kidney disease in patients with ADPKD, rather than palliative. Study participation will be available to physicians who have completed the appropriate education in all countries in Europe where JINARC is launched and commercially available by prescription. Patients must have never taken tolvaptan previously to be eligible to participate in the study.

Approximately 3000 patients will participate in the trial globally, with around 600 patients participating in the United Kingdom. Data will be collected from information from routine health check-ups collected from electronic medical records. In addition, a retrospective database analysis will be conducted to compare Adverse Events of special interest, such as glaucoma and skin neoplasms with non-treated patients.

An Educational Materials Effectiveness Survey will also be conducted to assess physicians' level of awareness and understanding of the content of the educational material received. Physicians who participate in this survey will not be able to enrol patients for prospective follow-up.

Project Details
Principal Investigator: Dr Rommel Ravanan
Planned End Date: 31/03/2022
Local Ref: 4042

BioResorce (Biobank)

The NIHR BioResource Rare Diseases (NIHRBRRD) aims to recruit participants with rare diseases and their relatives, to establish a comprehensive repository of consented participants.

The participants are being recruited based on their rare disease being the focus of one of the NIHR priority themes, namely: Infection & Immunity, Neuroscience, Rare Diseases (including Rare Cancers) and Cardiovascular Disease.

The NIHR BioResource Rare Diseases will isolate, analyse, collect and store DNA, plasma, sera samples on participants with rare diseases and their relatives. The aims are a) to use Next Generation Sequencing Techniques (NGST) which could include the sequencing of part, or all of the genome with the aim to determine the genetic basis of inherited rare diseases, including rare cancers for which the causative locus has hitherto not been identified, but which have potential wider relevance for the common diseases that are the focus of Biomedical Research Centres/Units (BRC/BRU) funded translational and experimental medicine research, and b) to advance discovery of genetic diagnoses for inherited and acquired genetic disorders, where the genotype causing phenotype is known, by developing next generation sequence technology based diagnostic tests covering NHS diagnostically-important genes.

Project Details
Principal Investigator: Dr Simon Satchell
Planned End Date: 31/03/2022
Local Ref: 3392

NEF301-OLE

Nefecon is an investigational medicinal product being developed by Calliditas Therapeutics AB as a modified-release (MR) capsule, and is being studied for the treatment of patients with primary immunoglobulin A (IgA) nephropathy (IgAN)(Also known as Berger Disease) at risk of developing end-stage renal disease (ESRD). Primary IgA Nephropathy is a kidney disease caused by an abnormal antibody (a type of protein) called Immunoglobulin A (IgA), and is the most common cause of glomerulonephritis worldwide, with estimates varying from 5% to more than 40% of patients with glomerular disease. Additionally, patients with a more severe form of the disease are at risk of progressing to end-stage renal disease.

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef 301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs).

Assuming that 75% of the patients who have completed Study Nef-301 will enter Study Nef-301 OLE, the total number of patients to be included is estimated to be approximately 250 patients, but up to 360 patients may be enrolled.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: TBC
Local Ref: 4883

UK Calciphylaxis

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

UNPACK2

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

SONAR-12M

If a person develops kidney failure, the build-up of toxins and fluid can be fatal within a few days if untreated. Patients with kidney failure need either a replacement kidney (kidney transplant) or for the excess fluid and toxins to be removed from the body (dialysis).

The commonest form of dialysis involves blood being filtered by a machine to remove toxins and excessive fluid (haemodialysis). This requires a brisk flow of blood through the machine to allow the toxins to be removed. The safest way to achieve sufficient flow in the machine is by joining one of the veins to one of the arteries in the arm (an arteriovenous fistula). With time, this fistula increases in size and allows sufficient flow dialysis nurses to put two needles into the fistula (one taking blood from patient to machine, the other returning the “cleansed” blood to the patient).

Unfortunately, up to half of arteriovenous fistulas fail within a year of being created. The reasons why this happens and how we can prevent it are largely unknown.

In 2018/2019 we ran the SONAR study, where patients underwent ‘Doppler ultrasound’ (a non-invasive scan that uses high-frequency sound waves to create a picture of the blood flow in the fistula) in an attempt to identify early problems with a fistula that may lead to it failing. In SONAR, we followed patients up for 10 weeks after their fistula operation performing 4 scans during that timeframe.

In SONAR-12M, we would like to ask the SONAR participants for consent to access their medical records to see if their fistulas are still functioning and ever provided good access for dialysis.

We want to find out whether ultrasound can successfully identify fistulas that might have problems so we can intervene early to try and prevent the fistula from failing.

Project Details
Principal Investigator: Mr Sam Turner
Planned End Date: TBC
Local Ref: 4913

FALCON

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

Paused Studies:

Pithia

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: TBC
Local Ref: 4119

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NBT Researcher

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Research & Innovation
North Bristol NHS Trust
Floor 3, Learning & Research Centre
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB

Telephone: 0117 4149330
Email: research@nbt.nhs.uk