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Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00369278
First received: August 25, 2006
Last updated: March 25, 2011
Last verified: March 2011
Results First Received: December 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplantation
Intervention: Drug: Enteric-coated mycophenolate sodium (EC-MPS)

  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
Intensified Mycophenolate Sodium Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)

Participant Flow:   Overall Study
    Intensified Mycophenolate Sodium     Standard Mycophenolate Sodium  
STARTED     63     65  
COMPLETED     39     44  
NOT COMPLETED     24     21  
Adverse Event                 14                 11  
Unsatisfactory therapeutic effect                 4                 5  
Protocol Violation                 2                 1  
Withdrawal by Subject                 2                 2  
Lost to Follow-up                 1                 0  
Graft loss                 1                 2  



  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.
No text entered.

Reporting Groups
  Description
Intensified Mycophenolate Sodium Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Total Total of all reporting groups

Baseline Measures
    Intensified Mycophenolate Sodium     Standard Mycophenolate Sodium     Total  
Number of Participants  
[units: participants]
  63     65     128  
Age  
[units: years]
Mean ± Standard Deviation
  52.4  ± 12.5     50.4  ± 14.6     51.4  ± 13.6  
Gender  
[units: participants]
     
Female     29     30     59  
Male     34     35     69  



  Outcome Measures
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1.  Primary:   Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L   [ Time Frame: Assessed on day 3, 10, 21, 42, 56 and 84 ]

2.  Primary:   Number of Participants With Any Treatment Failure   [ Time Frame: 6 months ]

3.  Secondary:   Number of Participants With Single Treatment Failures   [ Time Frame: 6 months ]

4.  Secondary:   Renal Function as Measured by Serum Creatinine   [ Time Frame: 6 months ]

5.  Secondary:   Renal Function as Measured by Glomerular Filtration Rate (GFR)   [ Time Frame: 6 months ]

6.  Primary:   Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Time to “Event” for the Composite Endpoint as Well as All Individual Components of That Endpoint “Treatment Failure” Including Clinical Rejections   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00369278     History of Changes
Other Study ID Numbers: CERL080ADE12
Study First Received: August 25, 2006
Results First Received: December 15, 2010
Last Updated: March 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices