Overview

Standard Therapy Using Tacrolimus, Mycophenolate Mofetil and Prednisone For Chronic Lung Transplant Rejection (BOS)

Status:
Not yet recruiting

Trial end date:
2028-06-30

Target enrollment:

Participant gender:

Summary

This is a prospective single-center, open-label, randomized, controlled pilot study in the treatment of chronic rejection (CR), defined as grade 1 and 2 BOS, in adult recipients of a pulmonary allograft (single or double lungs).To assess the efficacy and safety of sirolimus plus tacrolimus and prednisone (S) compared to standard therapy (tacrolimus, mycophenolate mofetil (MMF) and prednisone) (ST) for chronic rejection, defined as grades 1 and 2 bronchiolitis obliterans syndrome (BOS); BOS defined as ≥ 20% decline from maximal post-transplant FEV1.

Phase:

Phase 2

Details

Lead Sponsor:

University of Maryland, Baltimore

Treatments:

Mycophenolic Acid
Prednisone
Sirolimus
Tacrolimus