Safety, Pharmacokinetics, and Efficacy of AT-1501 in Patients Undergoing Kidney Transplant
Research type
Research Study
Full title
A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
IRAS ID
1004210
Contact name
Caroline Matthews
Contact email
Sponsor organisation
Eledon Pharmaceuticals, Inc.
Eudract number
2021-003830-36
Clinicaltrials.gov Identifier
Research summary
AT-1501 (the study medicine) is an experimental medicine for treating kidney transplant rejection. The normal function of the immune system is to attack any substance that it sees as foreign, such as a virus, however, when a person receives a transplanted organ, the immune system may attack the organ, causing it to be rejected. Current treatments prevent transplant rejection short-term, but are associated with side effects and rejection when given long-term. We hope that the study medicine will work to suppress the immune response after a kidney transplant, when given together with other standard of care (SOC) medicines, to reduce the chance of rejection and that it will also have fewer side effects than current medicines after long-term use.
This study will examine the safety, blood levels and effectiveness of the study medicine in up to 12 adult (18+) patients who are about to receive their first kidney transplant, when given as repeated infusions (slow injections) together with SOC post-transplant treatment.
Patients will take up to 16 months to finish the study during which they’ll have a 1 month screening period, a 12 month treatment period and a 3 month follow-up period. They’ll receive a total of 21 doses of the study medicine during the treatment period, on Days 1, 7, 14, 21 and 28 (1 month) post-transplant, followed by doses every 21 days until 12 months post-transplant, after which they will move to standard of care treatment.
The study will take place in up to 3 NHS hospitals who specialise in kidney transplant surgery.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0367
Date of REC Opinion
14 Dec 2021
REC opinion
Further Information Favourable Opinion