Standard Therapy Using Tacrolimus, Mycophenolate Mofetil and Prednisone For Chronic Lung Transpla… (NCT04415476) | Clinical Trial Compass
WithdrawnPhase 2
Standard Therapy Using Tacrolimus, Mycophenolate Mofetil and Prednisone For Chronic Lung Transplant Rejection (BOS)
Stopped: Study did not proceed to IRB approval.
0Started 2020-06-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age: 18 or older.
✓. Recipient of a single or double pulmonary allograft at least twelve months before study entry.
✓. Clinically diagnosed BOS grade 1 or 2
✓. Receiving oral TAC-based immunosuppression according to institutional standards.
✓. Capable of understanding the purposes and risks of the study, has given written informed consent and agrees to comply with the study requirements and capable of protocol adherence.
✓. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry.
✓. Stable to enable routine pre and post-transplant bronchoscopy with BAL and biopsy.