Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT06830798
Phase
PHASE3
Status
Recruiting
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Conditions

  • DGF
  • Delayed Graft Function
  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — DRUG
    Participants will receive ravulizumab via intravenous (IV) infusion.
  • Placebo — DRUG
    Participants will receive placebo via intravenous (IV) infusion.

Study Details

The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

Key Dates

Start date
May 19, 2025
Status verified
Apr 2026
Primary completion
Feb 4, 2028
Completion
Nov 6, 2028

Study Design

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

Arms

  • Experimental: Ravulizumab
    Participants will receive an IV dose of ravulizumab.
  • Placebo Comparator: Placebo
    Participants will receive an IV dose of placebo.

Primary Outcome Measure

Time to Freedom from Dialysis [ Time Frame: Through 90 days post-transplant ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94115-
Research SiteSan FranciscoCalifornia94143-
Research SiteStanfordCalifornia94305-
Research SiteNew HavenConnecticut06510-
Research SiteJacksonvilleFlorida32224-
Research SiteTampaFlorida33606-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60608-
Research SiteChicagoIllinois60637-
Research SiteFairwayKansas66205-
Research SiteLexingtonKentucky40508-
Research SiteKennerLouisiana70065-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteMinneapolisMinnesota55455-
Research SiteSt LouisMissouri63108-
Research SiteOmahaNebraska68198-
Research SiteLivingstonNew Jersey07039-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SiteDurhamNorth Carolina27705-
Research SitePhiladelphiaPennsylvania19140-
Research SiteGreenvilleSouth Carolina29605-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteCharlottesvilleVirginia22908-
Research SiteRichmondVirginia23298-
Research SiteSeattleWashington98104-
Research SiteMilwaukeeWisconsin53226-

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