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ALXN2030 in Antibody-Mediated Rejection After Kidney Transplantation
NCT06744647Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2025
- Primary completion
- Oct 2027
- Countries
- 8
- Sponsor
- Alexion Pharmaceuticals
- Modality
- Conjugated siRNA, Chemically Modified siRNA
- Drugs
- ALXN2030
- Conditions
- antibody mediated rejection (AMR)
01
Overview
Phase 2, randomised, double-blind trial of ALXN2030 in antibody mediated rejection (AMR) (3 arms), sponsored by Alexion Pharmaceuticals. Primary endpoint: Biopsy-proven histologic resolution at 52 weeks. Started Mar 2025; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo administered SC during the 52-week Double-Blind Treatment Period, followed by re-randomization to ALXN2030 in the OLE.
ALXN2030 Dose A
ALXN2030 Dose A administered SC during the 52-week Double-Blind Treatment Period and continuing into the OLE.
ALXN2030 Dose B
ALXN2030 Dose B administered SC during the 52-week Double-Blind Treatment Period and continuing into the OLE.
03
Who it enrols
Adult kidney transplant recipients (≥ 6 months post-transplant) with active or chronic active antibody-mediated rejection, eGFR ≥ 30 mL/min/1.73 m2, and body weight ≥ 50 kg. Excludes patients with recent acute rejection treatments or specific other nephropathies.
04
Endpoints
Primary
Biopsy-proven histologic resolution
Secondary
Biopsy-proven histologic resolution
Change From Baseline in biopsy-proven histologic scores
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Annualized Total eGFR Slope
Stabilized eGFR
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs)
Number of Participants With Anti-drug Antibodies (ADAs)
Plasma Concentration of ALXN2030
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