PRO-K-001
Research type
Research Study
Full title
A Phase 2 randomized, prospective, partial double-blind, placebo-controlled trial to evaluate the preliminary efficacy and safety of inhaled carbon monoxide upon kidney function in kidney transplant recipients.
IRAS ID
1007335
Contact name
Jeff Wager
Contact email
Sponsor organisation
PROTERRIS (PORTUGAL) LDA.
Research summary
The purpose of this study is to find out if inhaled carbon monoxide (iCO) is safe to use in people who are receiving a kidney transplant from a deceased donor.
Delayed graft function (DGF) is the failure of a transplanted kidney to function immediately following transplantation. When DGF occurs, dialysis is still needed for a period of time after the transplant. The study aims to find out if the risk of DGF developing right after surgery can be reduced through the use of inhaled carbon monoxide (iCO), without causing harmful side effects. This research is important because there are currently no effective therapies for the prevention of DGF. Benefits to taking part in the study may include improved kidney function after transplant (although this is not guaranteed) and new information learned that could help other kidney transplantation patients in the future.
To be eligible for the study, participants will need to be at a minimum:
- Male or female,
- Aged 18-75
- a kidney-only transplant recipient (from a deceased kidney donor)
- Medically stable
- Able to attend scheduled study visits
- Give written informed consent
- Female or male with a female partner who can get pregnant: be using an acceptable method of contraception or be post-menopausal, not pregnant or nursing.There will be two parts to the study: Part A, which will be an initial safety trial for the planned iCO dosing regimen, followed by Part B, which will evaluate safety of iCO as well the efficacy (how well it works) to reduce DGF in patients who have received kidney transplant tom a deceased donor. The study is multicenter and will take place in selected UK NHS sites. The study will last for approximately one year and participants will have an initial Screening period (duration 7 days), followed by Day 0 (randomization and kidney transplant surgery), Day 1, 2, 3, 7, 14, 28, 56 and 84.
Full visit procedures, inclusion and exclusion criteria are outlined in the study protocol.
REC name
Wales REC 1
REC reference
23/WA/0177
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion