A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01033864
First received: December 16, 2009
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: May 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Transplantation
Interventions: Drug: MMF
Drug: EC-MPS
Drug: Prednisone

  Participant Flow
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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
Mycophenolate Mofetil (MMF)/Prednisone Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.

Participant Flow:   Overall Study
    Mycophenolate Mofetil (MMF)/Prednisone     Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone  
STARTED     12     11  
COMPLETED     12     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
The pharmacokinetic (PK) population included all randomized participants.

Reporting Groups
  Description
MMF/Prednisone Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
EC-MPS/Prednisone Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
Total Total of all reporting groups

Baseline Measures
    MMF/Prednisone     EC-MPS/Prednisone     Total  
Number of Participants  
[units: participants]
  12     11     23  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 11.06     58.0  ± 8.04     59.8  ± 9.68  
Gender  
[units: participants]
     
Female     5     4     9  
Male     7     7     14  



  Outcome Measures
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1.  Primary:   Pre-dose Trough Concentration (C0)   [ Time Frame: Day 1 predose ]

2.  Primary:   Dose-Normalized C0   [ Time Frame: Day 1 predose ]

3.  Primary:   Minimum Plasma Concentration (Cmin)   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

4.  Primary:   Dose-Normalized Cmin   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

5.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

6.  Primary:   Dose-Normalized Cmax (mg/L)   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

7.  Primary:   MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

8.  Primary:   Dose-Normalized MPA AUC0-12   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

9.  Primary:   Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)   [ Time Frame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours ]

10.  Secondary:   Regression Coefficients For Participants Receiving MMF   [ Time Frame: Day 1 at 30 minutes and 1 and 2 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033864     History of Changes
Other Study ID Numbers: ML22641, 2009-012355-15
Study First Received: December 16, 2009
Results First Received: May 8, 2014
Last Updated: October 8, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte