Unclear endpoints and heterogeneous patients hinder CLAD trials
Evidence level: proposed bottleneck; synthesis of abstract-level sources; pending approval
An ISHLT consensus states that lung transplant trials have been hindered by unclear endpoints, and a preprint proposes trajectory classes for trial enrichment.
As of . Primary source: ISHLT consensus on trial endpoints (DOI).
Summary
The 2026 ISHLT consensus statement says clinical trials in lung transplantation have been hindered by a lack of clarity on the formulation and significance of endpoints beyond mortality, and developed Delphi-based recommendations including for CLAD. A 2026 preprint in two multicentre cohorts found four early FEV1 trajectory classes after probable CLAD with nine-month graft loss from 0 to 72 percent, and suggests a classification tool for trial enrichment. A prospective cohort of 745 recipients found 29.7 percent probable CLAD at 3 years with most progressing to definite CLAD. The ESOT guideline task force also emphasises urgent need for high-quality trials and standardised care pathways. The specific CLAD endpoints recommended were not read.
Details
- barrier type
- trial design
Sources and links
Related
Links from this record
- evidence: Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement
- evidence: Latent Class Analysis Identifies Pulmonary Function Trajectory Phenotypes in Lung Transplant Recipients with Chronic Allograft Dysfunction
- evidence: Prognosis and Risks for Probable Chronic Lung Allograft Dysfunction: A Prospective Multicenter Study
- evidence: European society for organ transplantation clinical practice guideline on prevention and treatment of chronic lung allograft dysfunction
- affects: A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
- affects: Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
- affects: Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts
- affects: ISHLT 2019 CLAD states: Potential, Possible, Probable and Definite
Known gaps in this record
- the CLAD endpoint recommendations themselves (full text not read)
- primary endpoints used by each registered trial linked here
Information resource only. Not medical advice. Not a substitute for the care of the patient's transplant team.