A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
argenx
Study ID
NCT06503731
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Antibody-mediated Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod PH20 SC - prefilled syringe — COMBINATION_PRODUCT
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Placebo PH20 SC - prefilled syringe — OTHER
    Subcutaneous placebo PH20 SC given by prefilled syringe

Study Details

The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation. After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Key Dates

Start date
Aug 30, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Treatment arm 1
    Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
  • Experimental: Treatment arm 2
    Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48
  • Placebo Comparator: Treatment arm 3
    Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 78 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) HospitalBirminghamAlabama35233
Navya Eleti, MD
[email protected]
857-350-4834
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Stanley Jordan, MD
[email protected]
857-350-4834
University of Chicago Medical CenterChicagoIllinois60615
Beatrice Concepcion, MD
[email protected]
857-350-4834
University of Nebraska Medical CenterOmahaNebraska68198
Eric Langewisch, MD
[email protected]
857-350-4834
Duke University HospitalDurhamNorth Carolina27705
Goni Katz-Greenberg, MD
[email protected]
857-350-4834
The Ohio State University Wexner Medical CenterColumbusOhio43210
Todd Pesavento, MD
[email protected]
857-350-4834
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant CenterRichmondVirginia23298
Gaurav Gupta, MD
[email protected]
857-350-4834
University of Washington Medical CenterSeattleWashington98195
Nicolae Leca, MD
[email protected]
857-350-4834

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB) Hospital· Birmingham, ALCedars-Sinai Medical Center· Los Angeles, CAUniversity of Chicago Medical Center· Chicago, ILUniversity of Nebraska Medical Center· Omaha, NEDuke University Hospital· Durham, NCThe Ohio State University Wexner Medical Center· Columbus, OH

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