Status:
WITHDRAWN
Standard Therapy Using Tacrolimus, Mycophenolate Mofetil and Prednisone For Chronic Lung Transplant Rejection (BOS)
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Disorder Related to Lung Transplantation
Chronic Rejection of Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 allog...
Detailed Description
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 allog...
Eligibility Criteria
Inclusion
- 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.
- Fasting cholesterol \< 250 mg/dL, fasting triglycerides \< 250 mg/dL -
Exclusion
- Active bacterial, viral or fungal infection not successfully resolved at least 4 weeks prior to study entry.
- Mechanical ventilation.
- At screening FEV1 \< 1 liter and/or \< FEV1 of 25 % predicted.
- Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy.
- Women who breastfeed.
- Known hypersensitivity to sirolimus.
- Serum creatinine value of \> 2.5 mg/dL or chronic dialysis use or liver disease with a bilirubin \> 2 mg/dL.
- Subjects with severe underlying disease other than BOS that is thought to become fatal within four months of clinical assessment.
- Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to study entry. This is defined as any treatment that is implemented under an Investigational New Drug.
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
- Any co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the patient's participation in the clinical trial.
- Clinically significant bronchial strictures unresponsive to dilatation procedures.
- Subjects with malignancy diagnosed within one year prior to screen (with the exception of skin cancers).
- Lipid panel fasting cholesterol \> 250 mg/dL, fasting triglycerides \>250 mg/dL
- \-
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04415476
Start Date
June 30 2020
End Date
June 30 2028
Last Update
May 6 2023
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