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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT06744647
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ALXN2030 — DRUG
    ALXN2030 will be administered subcutaneously (SC).
  • Placebo — DRUG
    Placebo will be administered SC.

Study Details

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.

Key Dates

Start date
Mar 7, 2025
Status verified
Apr 2026
Primary completion
Oct 11, 2027
Completion
Nov 7, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo will be administered during the Double-Blind Treatment Period of 52 weeks.
  • Experimental: ALXN2030 Dose A
    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).
  • Experimental: ALXN2030 Dose B
    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.

Primary Outcome Measure

Biopsy-proven histologic resolution [ Time Frame: Week 52 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35249-
Research SiteScottsdaleArizona85259-
Research SiteLos AngelesCalifornia90095-
Research SiteOrangeCalifornia92868-
Research SiteTampaFlorida33606-
Research SiteAtlantaGeorgia30309-
Research SiteKansas CityKansas66160-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteLivingstonNew Jersey07039-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10032-
Research SiteDurhamNorth Carolina27705-
Research SiteCincinnatiOhio45267-
Research SitePhiladelphiaPennsylvania19140-
Research SiteCharlestonSouth Carolina29425-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteRichmondVirginia23298-
Research SiteSeattleWashington98195-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Scottsdale, AZResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· Tampa, FLResearch Site· Atlanta, GA

Related Studies