Belumosudil for Chronic Renal Rejection

Overseen By Shondra Word

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Methodist Hospital Research Institute

Must be taking: Immunosuppressants

Must not be taking: High intensity statins

Disqualifiers: Heart disease, Severe liver disease, Malignancies, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called belumosudil to determine its effectiveness in protecting kidney transplants from damage that leads to failure. It targets individuals who have recently received a kidney transplant and are following a standard treatment plan to prevent rejection. Participants will take a daily dose of the drug or a placebo for 12 months. Suitable candidates include those receiving their first or second kidney transplant, provided their first transplant wasn't lost due to early rejection or disease recurrence. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop anticoagulation therapy one week before and after a kidney biopsy. You also need to follow FDA guidelines for contraception while using mycophenolic acid.

Is there any evidence suggesting that belumosudil is likely to be safe for humans?

Research has shown that belumosudil is generally safe for people. The FDA has already approved it to treat chronic graft-versus-host disease (cGVHD), a condition some patients experience after a transplant. This approval indicates that the drug has passed several safety tests for other uses.

In earlier studies, some people experienced mild side effects like headaches or nausea, but these were not serious for most. It's important to remember that while the treatment appears promising, individual reactions may vary. Always consult your healthcare provider to understand what to expect and whether this trial is a good fit for you. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic renal rejection?

Belumosudil is unique because it targets a specific pathway involved in chronic renal rejection by inhibiting the ROCK2 enzyme, which plays a role in immune response and inflammation. Unlike standard treatments that mainly focus on general immunosuppression, Belumosudil offers a more targeted approach, potentially reducing side effects associated with broader immunosuppressive therapies. Researchers are excited because this precision in targeting could lead to better outcomes and improved kidney function for patients experiencing chronic rejection.

What evidence suggests that belumosudil might be an effective treatment for chronic renal rejection?

Research has shown that belumosudil, which participants in this trial may receive, may help prevent kidney transplant rejection by reducing scarring in the transplanted kidney. Studies have found that belumosudil can decrease the need for corticosteroids, often used to manage transplant rejection. In one study, 67% of participants lowered their corticosteroid dose, and 19% stopped using them completely. This suggests that belumosudil can help manage long-term kidney issues and improve transplant success. The treatment targets a specific pathway linked to scarring, potentially reducing damage in transplanted kidneys. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for new kidney transplant patients. It's testing if a drug called belumosudil can prevent scarring and damage in the transplanted kidneys, which could lead to graft loss. Participants must be on standard immunosuppression therapy.

Inclusion Criteria

I am getting my first or second kidney transplant, and my first wasn't lost to rejection or disease in the first year.

I agree to follow specific lifestyle guidelines for the study.

Panel of reactive antibodies (PRA) <80% based on the most recent results

Exclusion Criteria

I have been diagnosed with focal segmental glomerulosclerosis.

My kidney donor is a perfect match or completely different.

I received a kidney transplant with both kidneys from one donor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200mg/day of belumosudil or placebo for 12 months to prevent interstitial fibrosis and tubular atrophy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in eGFR and biomarkers of fibrosis

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belumosudil

Trial Overview The study compares two groups: one taking the drug belumosudil (200 mg daily) and another taking a placebo, with both groups also receiving standard care post-transplant. The goal is to see if belumosudil reduces kidney scarring.

How Is the Trial Designed?

Group I: Belumosudil Experimental Treatment 1 Intervention

200mg/day belumosudil for 12 months

Group II: Placebo Placebo Group 1 Intervention

Daily placebo for 12 months

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a proof-of-concept study involving 12 kidney transplant recipients, a regimen combining belatacept, mycophenolic acid, steroids, and rabbit anti-thymocyte globulin significantly reduced acute rejection rates, with only 2 out of 12 patients experiencing rejection.

The study demonstrated that this treatment approach was safe, as no patients developed serious complications like post-transplant lymphoproliferative disorder, and all patients maintained their grafts without any deaths during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belatacept-based, ATG-Fresenius-induction regimen for kidney transplant recipients: a proof-of-concept study. Cicora, F., Mos, F., Petroni, J., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06751602

Belumosudil for Abrogation of Interstitial Fibrosis and ... This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of belumosudil (brand name- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725011595

Analysis of Long-Term Results from the KD025-208 and ... The long-term results from this pooled analysis of these two phase 2 studies demonstrated belumosudil was associated with durable responses, and it remained ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423532/

ROCK 2 inhibition with belumosudil for the treatment of ... During belumosudil treatment, 67% of participants reduced their corticosteroid dose and 19% successfully discontinued corticosteroid therapy.

4. nature.com nature.com/articles/s41409-025-02554-w

Efficacy and safety of belumosudil for treatment of cGVHD Median overall survival (OS) from transplantation date was not reached and 6-, 12- and 48-months OS were 97.1%, 95.6% and 90.6% respectively.

5. withpower.com withpower.com/trial/immunological-tolerance-therapy-for-kidney-transplant-rejection-72420

Immunological Tolerance Therapy for Kidney Transplant ... This trial tests if Belumosudil can help kidney transplant patients accept their new kidney without long-term immune-suppressing drugs.

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT05806749

Kidney Transplant - UC Clinical Trials This study seeks to determine if administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance in subjects ...

7. astctjournal.org astctjournal.org/article/S2666-6367(23)01359-3/fulltext

Belumosudil Impacts Immunosuppression ... Belumosudil (BEL) is a novel Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor approved for the treatment of chronic ...