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Oxford University Hospitals NHS Foundation Trust
Oxford Kidney Unit

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Research studies currently recruiting

Updated April 2018

This information is about research projects and clinical trials that are recruiting in the Oxford Renal and Transplant Unit.

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

COPE - POMP Trial

We are recruiting to this trial in this unit. This is for recipients of renal transplants where both of the pair of donor organs are randomised prior to implantation into the recipient.

'In house' Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors.
Summary

A multi-centre, participant-blinded, randomised, 24-month, parallel-group, prospective superiority study to compare the efficacy of brief 'in house' oxygenated hypothermic machine perfusion prior to transplantation of extended criteria donor kidneys from brain dead donors versus static cold storage alone to enhance 1 year graft survival after transplantation.
Recipients of these grafts are recruited into the study and followed up by the research team for one year after transplantation.

Professor Rutger Ploeg is the Investigator in charge of this trial here in Oxford.

For more information please visit: www.cope-eu.org

Determinants of Quality of Life in dialysis patients and their carers

A questionnaire-based study to determine quality of life and psychosocial factors in dialysis patients and their partners from before dialysis to the three month point.

Currie Moore, a PhD student, is in charge of this study, based in Manchester.

For information in Oxford, please contact the renal research team: RenalandTransplantTrials@ouh.nhs.uk

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