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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
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
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Research Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Orange, California, United States
RECRUITINGResearch Site
Tampa, Florida, United States
RECRUITINGResearch Site
Atlanta, Georgia, United States
RECRUITINGResearch Site
Kansas City, Kansas, United States
RECRUITINGResearch Site
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGResearch Site
Detroit, Michigan, United States
RECRUITINGResearch Site
Livingston, New Jersey, United States
RECRUITING...and 45 more locations