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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 : Completed
First Posted : May 27, 2009
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Information provided by (Responsible Party):
Tammy Ojo Clark, MD, 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
Cystic Fibrosis Lung Transplant

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pharmacokinetics of Mycophenolic Acid in Cystic Fibrosis Lung Transplant Recipients
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Cystic fibrosis
Lung transplant patients with cystic fibrosis. Measuring MPA levels in cystic fibrosis lung transplant patients for pharmacokinetic parameters.
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.

Primary Outcome Measures :
  1. Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients. [ Time Frame: 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose ]
    The AUC is the area under the concentration-time curve from time 0 to 12 hours. The AUC is measured in units of micrograms of mycophenolic acid (MPA) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L) and in units of micrograms of mycophenolic acid glucuronide (MPAG) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L). Apparent oral clearance (CL/F) was calculated by dose/AUC0-12.

Secondary Outcome Measures :
  1. Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression. [ Time Frame: 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose ]

    Inter- and intra-patient variability will be calculated by the coefficients of variation (CV) of the MPA AUC (mg*h/L).

    To analyze the intra- and interindividual variability, the coefficient of variation (CV) was calculated by dividing the standard deviation by the mean of the PK parameters from the 3 PK visits and the 5 study patients in each group, respectively. Inter-individual CVs presented are only comparing within the individuals per arm, not across or between arms.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung transplant patients with and without cystic fibrosis.

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
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Principal Investigator: Tammy Ojo, MD University of Michigan
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Responsible Party: Tammy Ojo Clark, MD, Assistant Professor of Internal Medicine, University of Michigan Identifier: NCT00908830    
Other Study ID Numbers: UM 20989
First Posted: May 27, 2009    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Cystic Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases