Research studies currently recruiting
Updated December 2019
This information is about research projects and clinical trials that are recruiting in the Oxford Renal and Transplant Unit.
The UK Calciphylaxis Study
Calciphylaxis or 'calcific uraemic arteriolopathy' is a rare condition which can occur in patients with Chronic Kidney Disease. It is the build-up of calcium and phosphate in the body which causes chalky deposits to form in the small blood vessels which can have a damaging effect in the body.
This is a prospective observational study over 10 years.
Patients newly diagnosed with this disease will be approached for recruitment. Sampling and data are sent to the coordinating centre in Salford Royal NHS Foundation Trust and DNA samples will be analysed in the University of Manchester.
The local PI for this study is Dr Ed Sharples.
UK Calciphylaxis Study - www.gmann.co.uk
Rituximab for standard treatment resistant idiopathic Membranous Nephropathy in adults
This is an evaluation scheme developed by NHS England for future commissioning of Rituximab.
Patients need to be registered on the RaDaR database when newly diagnosed and not had any other treatment regimens.
Two doses of this drug are given intravenously and the patients are followed up for 24 months for data and outcomes which is fed back to NHS England.
Recruitment will take place in Renal units involved all over England.
Dr Philip Mason is overseeing this project in Oxford.
SOLSTICE 303
Maribavir treatment for transplant recipients being treated for cytomegalovirus (CMV)
SOLSTICE is a clinical research study designed to explore an investigational drug – maribavir in transplant recipients whose CMV infections are not responding to current treatments.
Local PI is Dr Philip Mason.
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir - www.shiretrials.com
NephroS
National Study of Nephrotic Syndrome - NephroS
Nephros is a national study looking at patients with Steroid Resistant or Steroid Sensitive Nephrotic syndrome. This involves some blood tests and genetic screening.
By comparing blood samples the Study hopes to identify specific Nephrotic Syndrome Factors that cause recurrence of the disease.
Local PI is DrKatherine Bull.
NephroS Study - rarerenal.org
ASCEND clinical trials
We are recruiting to two trials for patients with renal anaemia, both being sponsored by GSK.
These are long-term multi-centre open label randomised controlled trials of a new tablet for renal anaemia versus the gold standard intravenous or sub cutaneous injection.
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Summary
The purpose of this multi-centre event-driven study in participants with anaemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
Primary Outcome Measures
Time to the first occurrence of adjudicated major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke); Randomisation (Day 1) to end of study (event-driven, up to 3.3 years); Mean change in hemoglobin (Hgb) between Baseline and efficacy period (EP) (mean over Weeks 28-52); Baseline and up to and including Week 52.
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Summary
The purpose of this multi-centre event-driven study in non-dialysis (ND) participants with anaemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
Primary Outcome Measures
Time to the first occurrence of adjudicated major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal myocardial infarction (MI) and non-fatal stroke); Randomisation (Day 1) to end of study (event-driven, up to 4.1 years); Mean change in hemoglobin (Hgb) between baseline and efficacy period (EP) (mean over Weeks 28-52); Baseline, up to and including Week 52.
Dr Philip Mason is the Consultant in charge of these trials here in Oxford.
If you are interested in participating, please contact the renal research team: RenalandTransplantTrials@ouh.nhs.uk
BISTRO Trial
BISTRO is a multi-centre trial with up to 35 dialysis centres across the country participating.
This is a randomised controlled study to determine if incorporation of bioimpedance (BI) into the dialysis setting of the post dialytic weight reduces loss of residual kidney function. The primary aim is to demonstrate a clinically significant lengthening in time to anuria in those randomised to the BI intervention group.
We aim to recruit 15+ patients to this study - who are new to dialysis and are passing urine. Patients who are willing to participate will be in the study for approximately 24 months.
Sheera Sutherland is the Researcher in charge of this trial here in Oxford.
If you are interested in participating, please contact the renal research team: RenalandTransplantTrials@ouh.nhs.uk
For more information please visit the study website: www.keele.ac.uk/bistro/aboutthestudy
RADAR
The National Registry of Rare Kidney Diseases (RaDaR) is an initiative by UK kidney specialists (the Renal Association). It is designed to pull together information from patients who have certain rare kidney diseases. This will give a much better understanding of how these illnesses affect people. It will also speed up research.
This work is done in partnership with patients. Where the research leads to practical benefits, such as better diagnosis, treatments or general advice this will be publicised on this website.
Dr Ed Sharples is the Consultant in charge of this project in Oxford.
We will be directly approaching suitable patients, but if you are interested please feel free to contact Karen Parsons.
EMPA-KIDNEY STUDY
The study of heart and kidney protection with empagliflozin.
EMPA-KIDNEY is a clinical trial initiated by kidney doctors and scientists based at the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) at the University of Oxford. The Oxford team is being supported by an academic collaboration spanning seven countries, including the United States, Canada, Germany, China, Japan, Malaysia and the United Kingdom.
EMPA-KIDNEY will recruit at least 5000 volunteers with chronic kidney disease to participate in the trial.
Further information is available on the trial website at www.empakidney.org
The international Chief Investigator is Dr Will Herrington (an Oxford Kidney Unit consultant).
Local PI is: Dr Richard Haynes
If you are interested in participating, please contact the renal research team: RenalandTransplantTrials@ouh.nhs.uk
CALISTA STUDY
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients.
CALISTA is an international, Phase 3, double-blind, placebo-controlled multicenter study that plans to enrol 111 adult patients with calciphylaxis. Eligible patients will be treated at participating medical centres in Canada, United States and United Kingdom over a three-week period to assess the effect of Sodium Thiosulfate on calciphylaxis-related pain.
Local PI is: Dr Udayaraj Udaya
Further information is available on the trial website at:
CALISTA | United Kingdom - clinicaltrials.gov
Impact of hemodialysis on the concentrations of sodium and potassium during infusion of sodium thiosulfate using an In Vitro hemodialysis model - journals.plos.org
Further information
Please watch this space for information on new trials and research projects starting in the Renal and Transplant Unit.
For further information about recruitment to these studies please email: RenalandTransplantTrials@ouh.nhs.uk