Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00908830|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
|Condition or disease|
|Cystic Fibrosis Lung Transplant|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
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.
- 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.
- 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.
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
|Principal Investigator:||Tammy Ojo, MD||University of Michigan|