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

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.

Timeline

Start

2020-06-30

Primary completion

2024-06-30

Completion

2028-06-30

Publications

• Results Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. doi: 10.1056/NEJMoa043204.

Drugs

Indications