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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.