ALXN2030-AMR-201 - ALXN2030 in Adult Pts. with Antibody-Mediated Rejection after Kidney Transplant
Research type
Research Study
Full title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients with Antibody-Mediated Rejection after Kidney Transplantation
IRAS ID
1012067
Contact name
Zara Butt
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to assess if ALXN2030 works better than placebo in adult participants with Antibody-mediated Rejection (AMR) after a kidney transplant. To evaluate how well ALXN2030 works, functional outcomes will be measured. The study also aims to assess, but not limited to, the side effects of ALXN2030, how often they happen and the severity of side effects compared to placebo, as well as evaluating the amount of ALXN2030 in the blood over time and the amount of complement component 3 (C3) and other immune proteins in the blood over time. ALXN2030 has been developed to address the unmet need for the treatment of patients who develop active or chronic AMR, after a kidney transplant. AMR is a common cause of kidney transplant failure, when the transplanted kidney does not work or stops working. AMR occurs when antibodies (immune system proteins) in the transplant recipient’s body cause an immune system reaction to the graft. There is no approved treatment for AMR. The study consists of 4 parts: Screening, Double-Blind Treatment Period (DBT), Open-Label Extension (OLE) Period and the Safety Follow Up (SFU) Period. Once the participant has completed screening and meets the eligibility criteria, they will enter 1 of the 3 treatment arms in the DBT period for 52 weeks: Treatment Arm 1 which is ALXN2030 at 450 mg on Day 1, then 150 mg at Week 4, then 150 mg every month alongside their standard of care treatment (SoC). Treatment Arm 2 which is ALXN2030 450 mg on Day 1, 450 mg at Week 4, then 450 mg every 3 months + their SoC treatment.
Treatment Arm 3 is the Placebo Arm, where participants would receive Placebo on Day 1, Week 4, then every month + their SoC treatment. ALXN2030 and the placebo will be given as a subcutaneous injection. In the OLE Period the participants assigned to placebo will be re-randomised into either ALXN2030 150 mg every month or 450 mg every 3 months + SoC treatment, this will last 52 weeks. Total study duration is 152 weeks.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0239
Date of REC Opinion
14 Nov 2025
REC opinion
Further Information Favourable Opinion