Back to search results

Phase 2 Study of ALXN2030 for Antibody-Mediated Rejection After Kidney Transplant

This study is testing a drug called ALXN2030 to see if it can help people who have antibody-mediated rejection (AMR) after a kidney transplant. AMR is when your body's immune system attacks the transplanted kidney. You could join if you are 18 to 75 years old, received a kidney transplant at least 6 months ago, and have active or chronic active AMR confirmed by a kidney biopsy and specific blood tests (C4d or HLA Class I and/or II antigen-specific DSA). The main goal is to see if ALXN2030 can resolve the rejection in your kidney biopsy after 52 weeks, compared to a placebo (an inactive substance). The study is currently unclear on its recruitment status and plans to enroll 45 participants.

Study design
This is a randomized, controlled, double-blind Phase 2 study. Participants will be randomly assigned to receive one of two doses of ALXN2030 or a placebo, with 45 participants planned.
What's involved
You would receive ALXN2030 or placebo subcutaneously (under the skin) for 52 weeks, along with standard care. You would also have repeated kidney biopsies at 28 and 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the 52-week treatment period, you may continue into an Open-Label Extension for another 52 weeks. Safety follow-up will continue until 48 weeks after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06744647

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

Active, Not Recruiting
PHASE2Ages 18–75InterventionalTreatment
Alexion Pharmaceuticals, Inc.
~47 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:ALXN2030Placebo

At a glance

Recruiting sites
0 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biopsy-proven histologic resolution
Measured over Week 52

Conditions

Antibody-Mediated Rejection
Kidney Transplantation
Biopsy-proven Histologic Scores
AMR

Explore related trials

Hyperacute graft rejectionC4dHLA class IMVI score

Where it's being run

51 sites across 25 states
China6
Brazil5
South Korea5
New York3
Spain3
Taiwan3
United Kingdom3
California2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Kidney transplant received ≥ 6 months
Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy
Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and/or positive HLA Class I and/or II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays
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 days prior to but no more than 3 years prior to Day 1
Must be vaccinated for S pneumoniae prior to randomization
Must be vaccinated for H influenzae type B (where available) prior to randomization
Body weight ≥ 50 kg at Screening

Exclusion

Biopsy-based diagnosis of any of the following at Screening:
TCMR, according to the Banff grade ≥ 1
Polyoma virus nephropathy
Severe thrombotic microangiopathy
Glomerulonephritis
ABO-incompatible transplant
uACR \> 2200 mg/g
Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient
Planned or recent treatments, \< 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \[except for tapering\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.
Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes

What this trial measures

  • Biopsy-proven histologic resolutionWeek 52