Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

The purpose of this study is to evaluate the safety and efficacy 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.

Eligibility criteria

Qualifiers

Able to understand and agree to participate in the study.

Have received a kidney transplant from a living or deceased donor (including re-transplants).

Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal.

Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.

Disqualifiers

Unable or unwilling to give consent or follow study rules.

Kidney transplant with incompatible blood types.

Very high levels of protein in urine, indicating severe kidney issues.

Previously had a non-kidney organ or bone marrow transplant.

Trial design

Treatments tested in this trial

  • Carfilzomib
  • Belatacept

Treatment groups

25 Participants
are divided into 1 treatment group