Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Evidence level: registry entry; no results posted
CTOT-47, a registered phase 2 placebo-controlled trial of belumosudil in lung transplant recipients at high risk of CLAD, sponsored by NIAID.
As of . Primary source: ClinicalTrials.gov NCT06476132.
Summary
The ClinicalTrials.gov entry describes a randomised, double-blind, placebo-controlled, multicentre phase 2 trial of belumosudil or placebo, given in addition to maintenance immunosuppression for 52 weeks, in participants whose lung biopsy shows acute rejection, lymphocytic bronchiolitis, organising pneumonia or acute lung injury. The registry lists the primary outcome as time from randomisation to the first occurrence of probable or definite CLAD under the ISHLT 2019 criteria, lung retransplant, or death. Enrolment is estimated at 234 participants. The registry text states that belumosudil is investigational for this use and that it is approved by the FDA for chronic graft-versus-host disease. No results are posted.
Details
- registry
- ClinicalTrials.gov
- registryId
- NCT06476132
- registryTitle
- Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)
- acronym
- CLAD
- sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- registryStatus
- recruiting
- phase
- Phase 2
- studyType
- interventional
- enrolment
- 234 (estimated)
- startDate
- 2025-03-12 (actual)
- primaryCompletionDate
- 2027-05-30 (estimated)
- intervention
- Belumosudil (drug); Placebo for Belumosudil (drug)
- condition
- Lung Transplant
- registryLastUpdatePosted
- 2026-08-10
- registryRead
- 2026-10-10
Sources and links
Related
Links from this record
- tests: Belumosudil
- uses criteria of: ISHLT 2019 CLAD states: Potential, Possible, Probable and Definite
- uses criteria of: Chronic lung allograft dysfunction: Definition, diagnostic criteria, and approaches to treatment: A consensus report from the Pulmonary Council of the ISHLT
Linked from (derived)
Known gaps in this record
- results: none posted in the registry
- participating centres and investigators: not recorded
- link to a CLADsolve centre record: not made
Information resource only. Not medical advice. Not a substitute for the care of the patient's transplant team.