Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00121810
First received: July 15, 2005
Last updated: April 13, 2011
Last verified: April 2011
Results First Received: November 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Transplantation
Interventions: Drug: mycophenolate mofetil [CellCept]
Drug: Corticosteroids
Drug: Calcineurin inhibitors
Drug: Sirolimus

  Participant Flow
  Hide 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
Mycophenolate Mofetil + Sirolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Participant Flow:   Overall Study
    Mycophenolate Mofetil + Sirolimus     Mycophenolate Mofetil + Cyclosporine or Tacrolimus  
STARTED     151     154  
Safety Population     148     153  
Intent-to-Treat (ITT) Population     148     151  
COMPLETED     121     115  
NOT COMPLETED     30     39  



  Baseline Characteristics
  Hide 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
Mycophenolate Mofetil + Sirolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Total Total of all reporting groups

Baseline Measures
    Mycophenolate Mofetil + Sirolimus     Mycophenolate Mofetil + Cyclosporine or Tacrolimus     Total  
Number of Participants  
[units: participants]
  148     151     299  
Age [1]
[units: years]
Mean ± Standard Deviation
  48.7  ± 12.90     48.7  ± 12.70     48.7  ± 12.80  
Gender [1]
[units: participants]
     
Female     55     55     110  
Male     93     96     189  
[1] Intent-to-treat population



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12   [ Time Frame: baseline to 12 months ]

2.  Secondary:   Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24   [ Time Frame: Baseline to 24 months ]

3.  Secondary:   Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24   [ Time Frame: baseline, 6, 12, and 24 months ]

4.  Secondary:   Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24   [ Time Frame: baseline 6, 12, and 24 months ]

5.  Secondary:   Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)   [ Time Frame: baseline, 6, 12, and 24 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


No publications provided


Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00121810     History of Changes
Other Study ID Numbers: ML17140
Study First Received: July 15, 2005
Results First Received: November 18, 2009
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration