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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
Sponsor:
Information provided by (Responsible Party):
Tammy Ojo Clark, MD, University of Michigan

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Conditions Cystic Fibrosis
Lung Transplant
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Hide Arm/Group Description

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

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Cystic Fibrosis Non-cystic Fibrosis Lung Transplant Total
Hide Arm/Group Description

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

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
30.6  (6.8) 59.4  (9.0) 45.0  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
3
  60.0%
3
  60.0%
6
  60.0%
Male
2
  40.0%
2
  40.0%
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 9
1.Primary Outcome
Title Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients.
Hide Description 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.
Time Frame 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Hide Arm/Group Description:

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

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg*h/L
MPA AUC 47.7  (13.7) 83.1  (27.9)
MPAG AUC 569  (204) 911  (249)
2.Secondary Outcome
Title Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression.
Hide Description

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.

Time Frame 0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Hide Arm/Group Description:

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

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: percent CV
MPA AUC..Intraindividual 16.6  (6.1) 13.8  (5.3)
MPA AUC..Interindividual 31.2  (1.5) 36.3  (5.6)
MPAG AUC..Intraindividual 16.6  (6.5) 15.9  (6.7)
MPAG AUC..Interindividual 37.3  (6.1) 27.8  (3.2)
Time Frame Up to 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Hide Arm/Group Description

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

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

Non-cystic fibrosis lung transplant patients. Non-cystic fibrosis lung transplant patients will have MPA levels drawn after their dose to determine pharmacokinetic parameters.

mycophenolate mofetil : Patients will take their own 500-mg tablets of mycophenolate mofetil

All-Cause Mortality
Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cystic Fibrosis Non-cystic Fibrosis Lung Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Since a comparative PK study with intravenous MMF was not conducted in our cohorts, the reason for the differences observed in the PK parameters between the 2 cohorts remains unknown.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Linda Stuckey, Pharm.D
Organization: University of Michigan Health System
Phone: 734-936-8129
Responsible Party: Tammy Ojo Clark, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00908830     History of Changes
Other Study ID Numbers: UM 20989
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: January 14, 2013
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018