Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients
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Purpose
Lung transplantation is a life saving procedure for patients with a terminal lung disease such as cystic fibrosis. Approximately, one in 3,500 children in the United States are born with cystic fibrosis each year with the predicted survival reaching 36.9 years in 2006. Cystic fibrosis was the third lead indication for lung transplantation in 2006. Cystic fibrosis is a genetic disease that can affect the way the body can remove salt from various organs. It results in mucus blocking the ducts of the lungs and pancreas leading to inability to handle oxygen and malabsorption of nutrients. Malabsorption is a common complication of cystic fibrosis that can affect the way the anti-rejection medications are absorbed. One medication that is utilized after transplant to prevent rejection is mycophenolate mofetil. This medication may not be absorbed adequately in this population due to their disease thus placing these patients at increased risk of rejection. At the investigators' institution, all transplant patients are initiated at the same mycophenolate dose regardless of their underlying disease. The limited available literature regarding cystic fibrosis transplant patients and mycophenolate suggests that these patients require higher doses due to their erratic absorption. The purpose of this study is to evaluate the effects of mycophenolate mofetil on the body in lung transplant patients who have cystic fibrosis in efforts to improve survival outcomes.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis Lung Transplant Patients |
Drug: mycophenolate mofetil |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Pharmacokinetics of Mycophenolic Acid in Cystic Fibrosis Lung Transplant Recipients |
- Characterize steady-state PK of MPA and MPAG in stable CF and non-CF lung transplant recipients. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Determine inter- and intra-patient variability of MPA exposure (AUC) in CF lung transplant recipients on tacrolimus based immunosuppression. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cystic fibrosis
Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.
|
Drug: mycophenolate mofetil
Patients will take thier own 500-mg tablets of mycophenolate mofetil
Other Name: Brand name = cellcept
|
|
Active Comparator: Non-cystic fibrosis lung transplant
Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.
|
Drug: mycophenolate mofetil
Patients will take thier own 500-mg tablets of mycophenolate mofetil
Other Name: Brand name = cellcept
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability and willingness to provide informed consent and be compliant with the study procedures
- Between 18-70 years of age
- Greater than 1 year post-transplant
- Have no evidence of acute rejection at 1 year post-transplant biopsy or within three months of study entry
- Stable mycophenolate mofetil dose
- Stable renal function
Exclusion Criteria:
- Serum creatinine greater than 2 mg/dl
- Received pulse steroids within 3 months of the study entry
- Chronic diarrhea
- Concurrently on interacting medications (cholestyramine, etc)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Tammy Ojo, MD; Transplant Pulmonologist, University of Michigan Hospital |
| ClinicalTrials.gov Identifier: | NCT00908830 History of Changes |
| Other Study ID Numbers: | UM 20989 |
| Study First Received: | May 26, 2009 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pulmonary Fibrosis Lung Diseases Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Mycophenolic Acid |
Mycophenolate mofetil Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013