We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University of Michigan.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908830
First Posted: May 27, 2009
Last Update Posted: October 12, 2017
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.
Information provided by:
University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of Mycophenolic Acid in Cystic Fibrosis Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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

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

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

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00908830


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

Responsible Party: Tammy Ojo, MD; Transplant Pulmonologist, University of Michigan Hospital
ClinicalTrials.gov Identifier: NCT00908830     History of Changes
Other Study ID Numbers: UM 20989
First Submitted: May 26, 2009
First Posted: May 27, 2009
Last Update Posted: October 12, 2017
Last Verified: August 2011

Additional relevant MeSH terms:
Fibrosis
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