Overview of the Research
Research is an important part of the work undertaken in the Bradford Renal Unit. Our focus is on clinical research, looking at treatment interventions that may improve the quality, safety and experience of care we provide for our patients. We have established a portfolio of local, regional, national and international projects.
The renal research team is based at St Luke’s hospital where we are involved in a variety of research studies involving patients from three main areas- nephrology, transplantation and dialysis, and our research activity covers all sites.
The research team has a broad membership and is currently led by Sister Jodi Paget, Sister Diane Palframan and our four Consultant Nephrologists Dr Tarun Bansal, Dr John Stoves, Dr Habib Akbani, Dr Russell Roberts and associate specialist in renal medicine Dr Ramla Mumtaz. All have an active interest in research and have been involved in a variety of commercial and non-commercial portfolio studies.
The Research Team
UK multicentre prospective open-label 2-arm randomised controlled trial of IV iron supplementation in incident haemodialysis patients
Sponsor: Kings College London
To determine the optimum strategy for administration of IV iron to incident haemodialysis patients
To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients
A study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis
Prospective observational study of prevalent PD patients receiving peritoneal dialysis
Sponsor: Keel University
Validating risk models for comparative outcomes of EPS in a contempary cohort of UK PD patients
Bone specific alkaline phosphatase and outcome in dialysis patients
Sponsor: East Kent Hospitals
To define an optimal range of bone ALP concentration in terms of morbidity and
A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.
Sponsor: Kings College London
Compare the time to graft failure in patients with HLA Ab who receive an optimized anti-rejection medication intervention (‘treatment’), with that in a control group with HLA Ab who remain on their established immunotherapy and whose clinicians are not aware of their Ab status.
Improving outcomes from peritonitis related infections (PERITPD). A study of immune responses in patients with acute PD peritonitis
Sponsor: Cardiff University
- a) Defining patient acute immune and cellular responses to different types of peritoneal infection
- b) Linking these “immune signatures” to definitive identification on the infecting organism
- c) Linking peritonitis and specifically the type of immune response and the infecting organism to patient outcomes
National Registry of Rare Kidney Diseases
Sponsor: The Renal Association
Primary Objective: to gather information from patients who with rare kidney diseases. This will give a much better understanding of how these illnesses affect people. It will also speed up research.
The UK Peritoneal Dialysis Outcomes and Practice Patterns Study
Sponsor: Sheffield University
Primary Outcome: To understand the impact of modifiable practices in the management of PD patients on the risk of all-cause PD technique failure.
Multi-centre Randomised Controlled Trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease;
The STOP-ACEi trial
Sponsor: Hull and East Yorkshire Hospitals NHS Trust
Primary Outcome: To test the hypothesis that stopping ACEi or ARB treatment or a combination of both, compared with continuing on these treatments, improves or stabilises renal function in patients with progressive stage 4 or 5 CKD based on assessment of renal function using the Modification of Diet in Renal Disease (MDRD) 4-variable estimated Glomerular Filtration Rate (eGFR) at 3 years follow-up
A double-blind, randomised, placebo-controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD)
Sponsor: Laboratoris Sanifit
Primary Outcome: change in coronary artery calcium volume scores after 52 weeks of treatment
Paclitaxel assisted balloon Angioplasty of Venous stenosis in haemodialysis access (PAVE); A double-blind randomised controlled clinical trial to determine the efficacy of paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access
Sponsor: Kings College London
Primary Outcome: Time to end of target lesion primary patency (TLPP).
A 6-year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients
Prescribed JINARC® for Autosomal Dominant Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceuticals
To characterise and quantify the identified risk of idiosyncratic liver injury in JINARC treated patients with ADPKD in routine clinical practice.
Survival Improvement with Colecalciferol in Patients on Dialysis – The SIMPLIFIED Registry Trial
Sponsor: University of Cambridge
Primary Outcome: All-cause mortality
QOL of Couples starting Dialysis
Determinants of quality of life in dialysis patients and their carers
Sponsor: Manchester University
QOL (WHOQOL-BREF) and the predictors are accepting dialysis, dialysis expectations and dyadic relationship characteristics.
FEPOD – Prospective Longitudinal Study of Assisted Peritoneal Dialysis, Haemodialysis and conservative kidney management in Older Patients with End Stage Kidney Disease
Sponsor – Imperial Hospitals London
To determine whether frail patients on assisted PD have improved outcomes (hospitalisation, physical function, quality of life and end of life management) compared to patients on HD. To compare non-dialysis therapy cost of assisted PD and HD for frail older patients (transport, outpatient and inpatient hospital visits and assistance for PD).
BIOMARKERS – Evaluation of Biomarkers for Diagnosis and Monitoring of Acute Post-Renal Transplant Complications.
Sponsor – University of Leeds
To validate diagnostic biomarkers of acute rejection, delayed graph function and chronic kidney transplant dysfunction using prospectively collected high quality clinical samples (blood and urine) from eligible patients.
ASTELLAS 1517 – A phase 3, Randomised, Double-Blind, Placebo Controlled study of the Efficacy and Safety of FG-4592 for the Treatment of Anaemia in Chronic Kidney Disease Patients not on Dialysis
Sponsor – INC Research
To evaluate the efficacy of roxadustat in the treatment of anaemia in non-dialysis Chronic Kidney Disease (CKD) subjects. Evaluate the safety of roxadustat in the treatment of anaemia in non-dialysis
CKD subjects. Evaluate health-related quality of life (HRQoL) benefit of treatment with roxadustat in subjects with CKD anaemia. Evaluate the need for anaemia rescue therapy with roxadustat treatment in subjects with CKD anaemia: red blood cell (RBC) transfusion, or Erythropoiesis-Stimulating Agent (ESA), or intravenous (IV) iron.
MEMBRANOUS – An investigation of factors (genetic, epigenetic, immune, biochemical and therapeutic) that modulate autoantibody production and specificity in patients with membranous nephropathy
Sponsor – University of Manchester
A prospective study of newly presenting incident and prevalent adult patients with biopsy proven membranous nephropathy. There has been a significant breakthrough in research recently showing that the disease is an autoimmune disease caused by antibodies. We recently identified two genes, DQA1 and PLA2R, that account for the risk of getting primary MN in a large European study. We now need to understand how this autoimmune mechanism and works. By observing which drugs best lower antibody production, we will be able to design effective future clinical trials.
ADPKD Study – A Multi-centre, Longitudinal, Observational Study of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression
Sponsor – Overture
To investigate the correlation between the rate of kidney enlargement and decline of renal function in ADPKD patients.
MIRCERA Trial – A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs.
Sponsor – ROCHE
To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke)
To assess the incidence of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA), gastrointestinal bleeding and thromboembolic events
IgA BRIGHT – A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy
Sponsor – Pharm Olam
This study is divided into 2 parts (A and B). All subjects will be on stable, optimized therapy with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), and the analyses will compare the effects of blisibimod plus ACEI/ARB therapy with placebo plus ACEI/ARB therapy.
The objective of Part A (from randomization through Week 24) is to assess the effect of blisibimod treatment on proteinuria.
The objective of Part B is to follow subjects for the occurrence of end-stage renal disease (ESRD) clinical events. The analysis for ESRD clinical events will include events accrued in this study (during Parts A and B) as well as in other concurrent placebo-controlled trials with blisibimod in patients with IgA nephropathy (e.g. Study AN-IGN3331).
Secondary objectives are to evaluate changes in proteinuria, immunoglobulins IgA, IgG, IgM, plasma cells, renal function, safety profile, requirement for steroid therapy and biomarker changes in subjects treated with blisibimod compared to placebo.
SPEAK – Surveying People Experiencing young Adult Kidney failure
Sponsor – University of Bristol
To investigate the question ‘How will having kidney failure affect my young adult life?’ The benefit of this will be to be able to provide an accurate picture of the sequelae of permanent renal failure and to obtain information on which factors might positively or negatively influence this, in particular which sub-groups are the most affected and why. This will enable the specific development of services in response to the data provided by this project to improve poor outcomes whilst maintaining the good. By defining the demography of the patients in this age group we can encourage the perception of young adults as an independent group who do not fit neatly into the way services are currently run for adults and paediatrics.
RISK – Risk Prediction For Acute Kidney Injury In Acute Medical Admissions In The UK
Sponsor – Royal Surrey County Hospital Foundation Trust
To collect clinical and biochemical data in unselected medical admissions from which risk prediction tools for the development of acute kidney injury (AKI) will be derived.