drugset / Trial / NCT06751602
Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2025-09-11
- Primary completion
- 2027-12
- Completion
- 2028-03-30
Publications
- Background Chen W, Chen W, Chen S, Uosef A, Ghobrial RM, Kloc M. Fingolimod (FTY720) prevents chronic rejection of rodent cardiac allografts through inhibition of the RhoA pathway. Transpl Immunol. 2021 Apr;65:101347. doi: 10.1016/j.trim.2020.101347. Epub 2020 Oct 24.
- Background Chen W, Chen S, Chen W, Li XC, Ghobrial RM, Kloc M. Screening RhoA/ROCK inhibitors for the ability to prevent chronic rejection of mouse cardiac allografts. Transpl Immunol. 2018 Oct;50:15-25. doi: 10.1016/j.trim.2018.06.002. Epub 2018 Jun 6.
- Background Subuddhi A, Uosef A, Zou D, Ubelaker HV, Ghobrial RM, Kloc M. Comparative transcriptome profile of mouse macrophages treated with the RhoA/Rock pathway inhibitors Y27632, Fingolimod (Gilenya), and Rezurock (Belumosudil, SLx-2119). Int Immunopharmacol. 2023 May;118:110017. doi: 10.1016/j.intimp.2023.110017. Epub 2023 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belumosudil | Small molecule | 200 mg | Oral |