Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06918990
Phase
PHASE1
Status
Recruiting
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Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

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

Interventions

  • Carfilzomib — BIOLOGICAL
    Administered by intravenous infusion over 60 minutes.
  • Belatacept — BIOLOGICAL
    Administered by intravenous infusion over 30 minutes.

Study Details

The purpose of this study is to evaluate the safety of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft injury. Participants will be followed for 52 weeks after starting investigational therapy, including protocol biopsies at 3 months and 12 months after start of investigational therapy. The study will also assess changes in immune cell responses, blood and urine biomarkers, and biopsy-based pathomic features associated with antibody-mediated graft injury.

Key Dates

First listed
Apr 9, 2025
Start date
May 27, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Treatment Arm
    Study Entry to Month-3 participants will receive: * Steroid pulse/taper * Kyprolis® (Carfilzomib) * Nulojix® (Belatacept) * Tacrolimus * Mycophenolate * Prednisone After 3 months participants will receive: * Belatacept + * Mycophenolate * Prednisone * Tacrolimus

Primary Outcome Measure

Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following: Grade 3 or higher infusion reaction, Grade 3 or higher infections, and any malignancy excluding localized non-melanomatous skin cancer. [ Time Frame: 3-months post randomization and 12-months post receipt of Investigational Therapy (IT) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama Medical Center (Site # 71136)BirminghamAlabama35294
Christy Taylor
[email protected]
205-934-8717
Mayo Clinic Arizona (Site # 71144)PhoenixArizona85054
Debbie Ryan
[email protected]
480-342-1208
UCLA Medical Center (Site #: 71123)Los AngelesCalifornia90024
Ahad Qureshi
[email protected]
310-794-8516
Northwestern University, Feinberg School of Medicine (Site # 71110)ChicagoIllinois60611
Sarah Tryon
[email protected]
312-926-1076
Washington University (Site # 71157)St LouisMissouri63110
Gwendolyn Amurao
[email protected]
314-362-4109
NYU Langone Health (Site # 71177)New YorkNew York10016
Kate Dzurilla
[email protected]
347-802-5853
Duke University (Site # 71139)DurhamNorth Carolina27710
Kitza Williams
[email protected]
919-681-1035
Christ Hospital (Site # 71195)CincinnatiOhio45267
Karen Case
[email protected]
513-585-1436
University of Cincinnati (Site # 71118)CincinnatiOhio45267
Pam Ringo
[email protected]
513-585-1436
Cleveland Clinic (Site # 71101)ClevelandOhio44195
Dianna Sendrey
[email protected]
216-444-0486
University of Wisconsin Madison (Site # 71112)MadisonWisconsin53726
Hannah Ranous
[email protected]
608-262-1295

Find similar trials in Birmingham, AL

By research site
University of Alabama Medical Center· Birmingham, ALMayo Clinic Arizona· Phoenix, AZUCLA Medical Center (Site #: 71123)· Los Angeles, CANorthwestern University, Feinberg School of Medicine· Chicago, ILWashington University· St Louis, MONYU Langone Health· New York, NY

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