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Small Molecule Inhibitor

Belumosudil for Lung Transplant (CLAD Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Single or bilateral lung transplant recipient age ≥ 12 years

Receiving Calcineurin Inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen

Must not have

Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).

Current use of sirolimus or everolimus.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

Awards & highlights

Summary

"This trial aims to see if a new drug called Belumosudil, when taken for 52 weeks along with regular care and medication, can prevent Chronic Lung Allograft Dysfunction (CLAD

Who is the study for?

This trial is for lung transplant recipients at high risk of developing CLAD, who have had a recent biopsy showing rejection or inflammation. Participants must be on usual care and medication post-transplant. Specific conditions like Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, or Acute Lung Injury in the biopsy qualify them.

What is being tested?

The study tests if Belumosudil can prevent Chronic Lung Allograft Dysfunction (CLAD) when taken for 52 weeks alongside standard post-transplant care. It compares the effectiveness of Belumosudil plus maintenance immunosuppression against a placebo with maintenance immunosuppression.

What are the potential side effects?

Potential side effects are not detailed here but may include those associated with immune system suppression such as increased infection risk and possible drug-specific reactions related to inflammation and scarring reduction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a lung transplant and am 12 years old or older.

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I am on a CNI-based drug to prevent organ rejection.

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My liver and kidney functions are within the required ranges for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I received a lung transplant from a donor with EBV, but I don't have EBV.

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I am currently using sirolimus or everolimus.

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I have tested positive for Hepatitis B.

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I haven't taken certain medications like anti-thymocyte globulin or alemtuzumab in the specified time before joining.

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I have had a transplant involving more than one organ type.

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I have had an organ or bone marrow transplant.

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My lung transplant came from a donor with Hepatitis B.

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I have had surgery or conditions that affect my lung function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or death

Secondary study objectives

Time from randomization to first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria) or lung retransplant

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nephrolithiasis

13%

Nausea

13%

Vomiting

13%

Anastomotic ulcer

13%

Somnolence

13%

Pyrexia

13%

Anastomotic ulder

13%

Hypokalemia

13%

Rib Fracture

13%

Fall

13%

Tooth ache

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Belumosudil plus maintenance ISExperimental Treatment1 Intervention

Eligible lung transplant recipients who experience a qualifying biopsy 90 to 410 days posttransplant will be randomized into the study. 200 mg of Belumosudil (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS will be administered daily for one year from randomization.

Group II: Placebo + maintenance ISPlacebo Group1 Intervention

Eligible lung transplant recipients who experience a qualifying biopsy 90 to 410 days posttransplant will be randomized into the study. Placebo plus maintenance immunosuppression (IS) will be administered for one year

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,302 Previous Clinical Trials

5,501,208 Total Patients Enrolled

5 Trials studying Lung Transplant

1,424 Patients Enrolled for Lung Transplant

Scott M. Palmer, M.D., M.H.S.Study ChairDuke University Medical Center: Transplantation

~156 spots leftby May 2027

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