Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALXN2030, Placebo.
- Who it may be relevant to
- Registry conditions: Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores, AMR. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Canada, China, South Korea +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation
Overview
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.
Detailed description
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.
Interventions
- Drug ALXN2030
ALXN2030 will be administered subcutaneously (SC). - Drug Placebo
Placebo will be administered SC.
Primary outcome measures
- Biopsy-proven histologic resolution [Time frame: Week 52]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Research Site — Birmingham
- Research Site — Scottsdale
- Research Site — Los Angeles
- Research Site — Orange
- Research Site — Tampa
- Research Site — Atlanta
- Research Site — Kansas City
- Research Site — Ann Arbor
- … and 15 more centers
Canada · 6 centers
- Research Site — Calgary
- Research Site — Edmonton
- Research Site — Vancouver
- Research Site — London
- Research Site — Toronto
- Research Site — Montreal
China · 6 centers
- Research Site — Changsha
- Research Site — Guangzhou
- Research Site — Nanning
- Research Site — Shanghai
- Research Site — Wuhan
- Research Site — Xi'an
Brazil · 5 centers
- Research Site — Botucatu
- Research Site — Campinas
- Research Site — Porto Alegre
- Research Site — São Paulo
- Research Site — São Paulo
South Korea · 5 centers
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
Taiwan · 4 centers
- Research Site — Kaohsiung City
- Research Site — Kaohsiung City
- Research Site — Taichung
- Research Site — Taoyuan
Spain · 3 centers
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Zaragoza
United Kingdom · 3 centers
- Research Site — Birmingham
- Research Site — London
- Research Site — London
Identifiers
NCT: NCT06744647 · D8560C00002