Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
NCT06751602 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-11-12
Summary
This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of belumosudil (brand name- REZUROCK®) on the background of standard immunosuppression will prevent fibrosis in the kidney transplant. Interstitial expansion is the precursor of interstitial fibrosis and graft loss. The hypothesis underlying the study is that abgrogating the fibrogenic effects of the RhoA pathway with belumosudil will reduce structural damage in transplanted kidneys and possible subsequent transplant failure.
Conditions
- Rejection Chronic Renal
Interventions
- DRUG
-
Belumosudil 200 mg QD
Belumosudil 200 mcg oral daily
- DRUG
-
Placebo (once daily)
Sponsors & Collaborators
-
The Methodist Hospital Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-11
- Primary Completion
- 2027-12-31
- Completion
- 2028-03-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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