At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ALXN2030 (drug), Placebo (drug)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- ALXN2030 — drug: ALXN2030 will be administered subcutaneously (SC). · Placebo — drug: Placebo will be administered SC.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 47
- Started
- 2025-03-07
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for antibody-mediated rejection
- • Phase2 - 47 participants
- • The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with antibody-mediated rejection
Where?
- • Birmingham - Research Site
- • London - Research Site
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
More detail
This prospective trial will assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN2030 in kidney transplant recipients with active or chronic active AMR. The study is designed as a randomized, controlled, double-blind phase 2 trial. Participants will be randomized in a 1:1:1 ratio to receive either ALXN2030 Dose A, ALXN2030 Dose B, or placebo for a double-blind treatment period of 52 weeks. All arms will receive standard of care immunosuppressive treatment. During the treatment period, study participants will be subjected to repeated allograft biopsies at 28 and 52 weeks. At the end of the double-blind treatment period, participants may continue into the Open-Label Extension (OLE) Treatment Period (52 weeks). Participants randomized to placebo will be re-randomized 1:1 to ALXN2030 Dose A or ALXN2030 Dose B. Safety Follow-Up will start after the end of Treatment (Week 104) until week 48 after the last dose.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Kidney transplant received ≥ 6 months
- ✓Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
- ✓MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)
- ✓eGFR ≥ 30 mL/min/1.73 m2
- ✓Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14...
Who cannot take part
- ✗Biopsy-based diagnosis of any of the following at Screening:
- ✗TCMR, according to the Banff grade ≥ 1
- ✗Polyoma virus nephropathy
- ✗Severe thrombotic microangiopathy
- ✗Glomerulonephritis
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Birmingham B15 2GW, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
London W12 0HS, United Kingdom
