Renal Research Team

PIVOTAL 

UK multicentre prospective open-label 2-arm randomised controlled trial of IV iron supplementation in incident haemodialysis patients

Sponsor: Kings College London

Primary Objective:

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

PDCRAFT

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

Primary Objective:

Validating risk models for comparative outcomes of EPS in a contempary cohort of UK  PD patients

ALPHA

Bone specific alkaline phosphatase and outcome in dialysis patients

Sponsor: East Kent Hospitals

Primary Objective:

To define an optimal range of bone ALP concentration in terms of morbidity and

mortality.

OuTSMART

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

Primary Objective:

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.

Perit PD

Improving outcomes from peritonitis related infections (PERITPD). A study of immune responses in patients with acute PD peritonitis

Sponsor: Cardiff University

Primary Objectives:

1. a) Defining patient acute immune and cellular responses to different types of peritoneal infection
2. b) Linking these “immune signatures” to definitive identification on the infecting organism
3. c) Linking peritonitis and specifically the type of immune response and the infecting organism to patient outcomes

RaDaR

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.

PDOPPS

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.

STOP ACEi

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

CALIPSO

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

PAVE

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).

OTSUKA

A 6-year, Multicentre, Non-interventional, Post-authorisation Safety Study for Patients

Prescribed JINARC® for Autosomal Dominant Polycystic Kidney Disease

Sponsor: Otsuka Pharmaceuticals

Primary Outcome:

To characterise and quantify the identified risk of idiosyncratic liver injury in JINARC treated patients with ADPKD in routine clinical practice.

SIMPLIFIED

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

Primary Outcome:

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.