Immunological Tolerance Therapy for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests if Belumosudil can help kidney transplant patients accept their new kidney without long-term immune-suppressing drugs. It targets patients with partially matched or slightly mismatched donors. The drug works by boosting special immune cells that help the body accept the new kidney.

Eligibility Criteria

Adults over 18 eligible for kidney and stem cell transplants can join this trial if they have a matched living donor, are not pregnant, agree to use contraception, live near UCLA Medical Center, and have good heart, liver, and lung function. Excluded are those with certain infections or diseases requiring immunosuppression, recent drug abuse history, very high BMI or previous organ transplants.

Inclusion Criteria

Adequate social support based on evaluation by the UCLA renal transplant team licensed clinical social worker

INR and/or PTT < 1.5X upper limits of institutional normal

I agree to use effective birth control methods if I'm of reproductive age.

Exclusion Criteria

I have been treated with rATG or am allergic to rabbit proteins.

Pregnant or lactating

INR and/or PTT ≥ 1.5X upper limits of institutional normal

Treatment Details

Interventions

• Belumosudil (Small Molecule)
• Donor CD34+, CD3+ (Cell Therapy)

Trial Overview The study is testing the safety and effectiveness of belumosudil in improving transplant tolerance when given alongside a combined kidney and hematopoietic stem cell transplant from either a half-matched related donor or an unrelated donor with minimal HLA mismatches.

Participant Groups

Group I: Immune tolerance in mismatched kidney transplant recipient Experimental Treatment 1 Intervention

Our goal is to establish this regimen as a novel, safe and effective approach for induction of transplant tolerance in HLA single haplotype-matched related and HLA mismatched unrelated recipients of combined Hematopoietic Stem Cell Transplant(HSCT)/ Kidney Transplant (KT). Patients will undergo conditioning with rATG and TLI, followed by infusion of hematopoeitic stem cells from the same donor, a triple immunosuppressive regimen, and receive belumosudil following the kidney transplant. Immunosuppression taper will be stopped and/or immunosuppression will be resumed for any of the following conditions: (1) loss of chimerism 2) clinical or pathological evidence of acute rejection and (3) clinical or pathological evidence of graft vs host disease.

Belumosudil is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as Rezurock for:

• Chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older after failure of at least two prior lines of systemic therapy

🇨🇦 Approved in Canada as Rholistiq for:

• Chronic graft-versus-host disease (cGVHD) in adult and pediatric patients 12 years or older

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Los Angeles Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

References