Trial record 1 of 804 for:    lung transplant
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Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00908830
First received: May 26, 2009
Last updated: August 3, 2011
Last verified: August 2011
  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

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 ] [ Designated as safety issue: No ]

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 ] [ 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908830

Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Tammy Ojo, MD University of Michigan
  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 July 29, 2014