Disorder Related to Lung Transplantation Clinical Trial
Official title:
A Randomized, Open-label,Controlled Phase II b Study to Demonstrate Efficacy and Safety of Sirolimus Chronic Rejection After Lung Transplant
Verified date | June 2020 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age: 18 or older. 2. Recipient of a single or double pulmonary allograft at least twelve months before study entry. 3. Clinically diagnosed BOS grade 1 or 2 4. Receiving oral TAC-based immunosuppression according to institutional standards. 5. 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. 6. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry. 7. Stable to enable routine pre and post-transplant bronchoscopy with BAL and biopsy. 8. Fasting cholesterol < 250 mg/dL, fasting triglycerides < 250 mg/dL - Exclusion Criteria: 1. Active bacterial, viral or fungal infection not successfully resolved at least 4 weeks prior to study entry. 2. Mechanical ventilation. 3. At screening FEV1 < 1 liter and/or < FEV1 of 25 % predicted. 4. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy. 5. Women who breastfeed. 6. Known hypersensitivity to sirolimus. 7. Serum creatinine value of > 2.5 mg/dL or chronic dialysis use or liver disease with a bilirubin > 2 mg/dL. 8. Subjects with severe underlying disease other than BOS that is thought to become fatal within four months of clinical assessment. 9. 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. 10. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures. 11. 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. 12. Clinically significant bronchial strictures unresponsive to dilatation procedures. 13. Subjects with malignancy diagnosed within one year prior to screen (with the exception of skin cancers). 14. Lipid panel fasting cholesterol > 250 mg/dL, fasting triglycerides >250 mg/dL - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | Increase in motility | 2 years | |
Primary | Re-Transplantation | Increase in re-transplantation from baseline | 2 years | |
Primary | FEV1 (Forced Respiratory Volume in 1 second) | Greater or equal to 20% decline in FEV1 from randomization | 2 years | |
Secondary | FVC (Forced Vital Capacity) | Caparison between the two treatment groups. | 2 years | |
Secondary | FEF (forced expiratory flow) | The rate of airflow recorded in measurements of forced vital capacity, usually calculated as an average flow over a given portion of the expiratory curve; the portion between 25 and 75 per cent of forced vital capacity.
Comparison on FEF(25-75) between the two treatment groups. |
2 years |
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