Study of UCB7858 in kidney transplant recipients with CAI
Research type
Research Study
Full title
A Multicenter, Randomized, Placebo-Controlled investigator-blind, participant-blind Study to Evaluate Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of zampilimab in Adult Kidney Transplant Recipients with Chronic Allograft Injury
IRAS ID
289029
Contact name
Anthony Dorling
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2017-004807-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
46020, NIHR registration number
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
The study is being performed in kidney transplant recipients who have deteriorating kidney function associated with chronic allograft injury (CAI), a condition where the function of the transplanted kidney has decreased due to build-up of scar tissue called fibrosis. The study drug is being developed to slow down the fibrosis that often eventually leads to kidney failure resulting in dialysis or another transplantation.
The study is divided into 2 stages – Stage 1 and Stage 2. The purpose of Stage 1 is to investigate how safe the study drug is and how well patients react to it (safety and tolerability) at different doses, and then determine the dose level for Stage 2. The purpose of Stage 2 is to further investigate the safety, tolerability and efficacy of repeat dosing with UCB7858 in these patients at the chosen dose level.
This study will involve approximately 177 patients (up to 24 in Stage 1 and 153 in Stage 2) in approximately 35 centres throughout Europe, Australia, and North America.
Stage 1 of the study typically consists of 3 parts (screening, treatment and follow up), in total lasting a maximum of 540 days (approximately 1 year 6 months).
Stage 2 is currently projected to open recruitment during the second quarter of 2021. Additional information will be provided to the Ethics Committee as a substantial amendment and will include a Stage 2 Patient Information Sheet and Consent Form. Patients from the UK won’t be recruited into this stage until the necessary Regulatory and Ethics approvals are received.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0050
Date of REC Opinion
24 Mar 2021
REC opinion
Further Information Favourable Opinion