Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908830
Recruitment Status : Unknown
Verified August 2011 by University of Michigan.
Recruitment status was:  Active, not recruiting
First Posted : May 27, 2009
Last Update Posted : August 4, 2011
Information provided by:
University of Michigan

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Lung Transplant Patients Drug: mycophenolate mofetil Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of Mycophenolic Acid in Cystic Fibrosis Lung Transplant Recipients
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Estimated Study Completion Date : March 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Characterize steady-state PK of MPA and MPAG in stable CF and non-CF lung transplant recipients. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Determine inter- and intra-patient variability of MPA exposure (AUC) in CF lung transplant recipients on tacrolimus based immunosuppression. [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908830

Sponsors and Collaborators
University of Michigan
Principal Investigator: Tammy Ojo, MD University of Michigan

Responsible Party: Tammy Ojo, MD; Transplant Pulmonologist, University of Michigan Hospital Identifier: NCT00908830     History of Changes
Other Study ID Numbers: UM 20989
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Cystic Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action