Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eledon Pharmaceuticals
Study ID
NCT06126380
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AT-1501 — DRUG
    AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
  • Tacrolimus — DRUG
    Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent

Study Details

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Key Dates

Start date
Oct 25, 2023
Status verified
Mar 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
132 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AT-1501
    AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
  • Active Comparator: Tacrolimus
    Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent

Primary Outcome Measure

Safety and Tolerability - Incidence of Treatment Emergent Adverse Events [ Time Frame: Assessed from date of enrollment through Month 48 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Keck School of Medicine of USCLos AngelesCalifornia90033-
University of California Los AngelesLos AngelesCalifornia90024-
University of California, Irvine Medical CenterOrangeCalifornia92868-
University of California, Davis Medical CenterSacramentoCalifornia95817-
Jacobs Medical Center at UC San Diego HealthSan DiegoCalifornia92037-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Tampa General HospitalTampaFlorida33606-
Emory University HospitalAtlantaGeorgia30322-
Augusta UniversityAugustaGeorgia30912-
University of ChicagoChicagoIllinois60637-
Loyola University Medical CenterMaywoodIllinois60153-
University of Kansas Medical CenterKansas CityKansas66160-
Tulane Medical CenterNew OrleansLouisiana70112-
John Hopkins UniversityBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
University of Minnesota Medical CenterMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55907-
Washington University in St. LouisSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
New York University Langone Health - Tisch HospitalNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Cincinnati Medical CenterCincinnatiOhio45219-
University of Pittsburgh Medical CenterHarrisburgPennsylvania17104-
UT SouthwesternDallasTexas75235-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Los Angeles, CA

By research site
Keck School of Medicine of USC· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CAUniversity of California, Irvine Medical Center· Orange, CAUniversity of California, Davis Medical Center· Sacramento, CAJacobs Medical Center at UC San Diego Health· San Diego, CAMedStar Georgetown University Hospital· Washington D.C., DC

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