A Phase 2 interventional study of ALXN2030 and Placebo in Antibody-Mediated Rejection, Kidney Transplantation and Biopsy-proven Histologic Scores, sponsored by Alexion Pharmaceuticals, Inc.. Active, not recruiting at 51 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Alexion Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
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.
Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.
Drug: Placebo
During the Double-Blind Treatment Period, participants will receive ALXN2030 dose A over 52 weeks. At Week 52, participants may continue into the Open Label Extension (OLE).
Drug: ALXN2030
During the Double-Blind Treatment Period, participants will receive ALXN2030 dose B over 52 weeks. At Week 52, participants may continue into the OLE Period.
Drug: ALXN2030
ALXN2030 will be administered subcutaneously (SC).
Placebo will be administered SC.
Biopsy-proven histologic resolution
Time frame: Week 52
Biopsy-proven histologic resolution
Time frame: Week 28
Change From Baseline in biopsy-proven histologic scores
Time frame: Baseline, Weeks 28 and 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline up to week 52
Annualized Total eGFR Slope
Time frame: Baseline up to Week 52
Stabilized eGFR
Time frame: Baseline up to Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 up to Week 104
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Day 1 through Week 104
Plasma Concentration of ALXN2030
Time frame: Baseline up to Week 104
Plasma Concentration of C3 Protein
Time frame: Baseline up to Week 104
Change From Baseline in Serum Complement Functional Activity
Time frame: Baseline, up to Week 52 and up to Week 104
Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Alexion Pharmaceuticals, Inc.