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Oxford University Hospitals NHS Foundation Trust
Oxford Kidney Unit

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Research studies currently recruiting

Updated January 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

EndoAVF Post-Market Study

This is a study evaluating a device used in the creation of an endovascular fistula in patients needing vascular access for haemodialysis.

We are part of a worldwide study which is recruiting 200 patients and individual follow up is for 12 months.

The local PI for this study is Mr James Gilbert.

everlinQ endoAVF receives FDA de novo marketing approval - vascularnews.com

YouTube videos of the procedure: search as EndoAVF

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

The Sonar Trial

Surveillance Of arterioveNous fistulAe using ultRasound

A study to determine whether ultrasound surveillance can predict arteriovenous fistula failure in patients with chronic kidney disease.

10 week follow-up period using four ultrasound scans.

Local PI is Mr Simon Knight.

The Sonar Trial - www.sonartrial.org.uk

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.

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