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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cystic Fibrosis

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

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


Participant Flow:   Overall Study
    Cystic Fibrosis   Non-cystic Fibrosis Lung Transplant
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cystic Fibrosis

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

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 Total of all reporting groups

Baseline Measures
   Cystic Fibrosis   Non-cystic Fibrosis Lung Transplant   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.6  (6.8)   59.4  (9.0)   45.0  (16.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  60.0%      3  60.0%      6  60.0% 
Male      2  40.0%      2  40.0%      4  40.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   9 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: lindastu@med.umich.edu



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