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Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients (OLYMPE)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00284934
First received: January 30, 2006
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Diseases
Interventions: Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Drug: Tacrolimus
Drug: Corticosteroids

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Dose EC-MPS Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
High EC-MPS Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.

Participant Flow:   Overall Study
    Standard Dose EC-MPS     High EC-MPS  
STARTED     48     46  
Intent-to-treat Population (ITT)     47     45  
COMPLETED     44     43  
NOT COMPLETED     4     3  
Adverse Event                 1                 2  
Other reasons                 3                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Standard Dose EC-MPS Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
High EC-MPS Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
Total Total of all reporting groups

Baseline Measures
    Standard Dose EC-MPS     High EC-MPS     Total  
Number of Participants  
[units: participants]
 		  47     45     92  
Age  
[units: Years]
Mean ± Standard Deviation 		  54.5  ± 10.4     50.7  ± 12.2     52.7  ± 11  
Age, Customized  
[units: Participants]
 		     
< 45     11     13     24  
45-60     18     20     38  
>= 60     18     12     30  
Gender  
[units: participants]
 		     
Female     16     15     31  
Male     31     30     61  



  Outcome Measures
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1.  Primary:   Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)   [ Time Frame: Baseline and Month 6 ]
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2.  Secondary:   Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)   [ Time Frame: Baseline and 3 months ]
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3.  Secondary:   Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months   [ Time Frame: 6 months ]
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4.  Secondary:   Number of Participants With Graft and Patient Survivals at 6 Months   [ Time Frame: 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00284934     History of Changes
Other Study ID Numbers: CERL080AFR04
Study First Received: January 30, 2006
Results First Received: December 20, 2010
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)