Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

Conditions

• Rejection Chronic Renal

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Belumosudil 200 mg QD — DRUG
  Belumosudil 200 mcg oral daily
• Placebo — DRUG
  Placebo (once daily)

Study Details

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.

Key Dates

Start date

Sep 11, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2027

Completion

Mar 30, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Belumosudil
  200mg/day belumosudil for 12 months
• Placebo Comparator: Placebo
  Daily placebo for 12 months

Primary Outcome Measure

Difference in Severe Treatment-Emergent Adverse Events within 12 Months [ Time Frame: Time of first dose to 12 months after first dose (study drug/placebo) ]

Locations (1)

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