RENAPAIR 02
Research type
Research Study
Full title
A 3-month, phase 2, single-blind, randomised, no-treatment controlled study assessing efficacy and safety of Renaparin® for improvement of kidney graft function in deceased-donor transplant recipients, with an additional 9-month follow-up.
IRAS ID
1006487
Contact name
Amanda Knock
Contact email
Sponsor organisation
Corline Biomedical AB
Eudract number
2021-003787-27
Research summary
This study is a phase II multi-national (Germany, Austria and UK), multi-centre (approx 10 sites), randomised, no-treatment controlled study assessing efficacy and safety of Renaparin® for improvement of kidney graft function in deceased-donor transplant recipients, with an additional 9-month follow-up.
The study will include patients with end-stage renal disease or an insufficient kidney function who are having a kidney transplant from a deceased donor. Renaparin® is under development for the prevention of damages that can occur to the kidney when the organ is reperfused with blood during transplantation. These damages are more typical for kidneys from deceased donors. Renaparin® may reduce local clotting events and inflammatory responses to the kidney and thus Renaparin® may improve the kidney function directly after transplantation. Patients undergoing transplantation will either receive a kidney with Renaparin® administered directly to it outside of the body prior to the transplantation or transplantation according to standard of care without Renaparin®.
Approximately 80 patients requiring a kidney transplant will be included in this study, The screening visit (day-1 to day 0) will include a review of the eligibility for the study, a physical examination, review of vital signs and blood and urine samples collected as part of the safety assessment along with checking patient's general health prior to transplantation. Treatment and transplantation will take place on day 0, for patients randomised to receive a Renaparin® treated kidney, the Renaparin® will be added to the kidney at least 90 minutes prior to transplantation. After transplantation the standard of care transplantation schedule will be followed with 7 days hospitalisation. Health checks will be performed from day 1 to day 7. The patients will then attend the clinical site for follow up health checks at month 1, 3, 6 and 12.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0243
Date of REC Opinion
21 Nov 2022
REC opinion
Further Information Favourable Opinion