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A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

This study has been completed.
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377637
First received: September 15, 2006
Last updated: October 31, 2011
Last verified: October 2011
Results First Received: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lupus Nephritis
Interventions: Drug: Mycophenolate mofetil (MMF)
Drug: Cyclophosphamide
Drug: Azathioprine
Drug: Placebo to Azathioprine
Drug: Placebo to Mycophenolate mofetil
Drug: Corticosteroid

  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
The induction phase was a prospective, randomized, open-label, active controlled, parallel group, international multicenter, 2-arm comparison study of MMF versus IVC in inducing a response in patients with Lupus nephritis. Responders in the induction phase were re-randomized into a double-blind, double-dummy, active controlled Maintenance Phase.

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
Induction Phase: Cyclophosphamide Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
Induction Phase: Mycophenolate Mofetil Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
Maintenance Phase: Mycophenolate Mofetil Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
Maintenance Phase: Azathioprine Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.

Participant Flow for 2 periods

Period 1:   Induction Phase
    Induction Phase: Cyclophosphamide     Induction Phase: Mycophenolate Mofetil     Maintenance Phase: Mycophenolate Mofetil     Maintenance Phase: Azathioprine  
STARTED     185 [1]   185 [1]   0     0  
Safety Population     180     184     0     0  
COMPLETED     156     150     0     0  
NOT COMPLETED     29     35     0     0  
Adverse Event                 12                 21                 0                 0  
Deterioration/serum creatinine                 2                 0                 0                 0  
Dose reduction of MMF < 2 g/day for 14 d                 0                 1                 0                 0  
Lost to Follow-up                 2                 1                 0                 0  
Death                 1                 3                 0                 0  
Withdrawal by Subject                 5                 6                 0                 0  
Physician Decision                 3                 1                 0                 0  
Sponsor decision                 1                 2                 0                 0  
Non-Compliance                 1                 0                 0                 0  
Reason for withdrawal is not noted                 2                 0                 0                 0  
[1] Intent-To-Treat

Period 2:   Maintenance Phase
    Induction Phase: Cyclophosphamide     Induction Phase: Mycophenolate Mofetil     Maintenance Phase: Mycophenolate Mofetil     Maintenance Phase: Azathioprine  
STARTED     0     0     116     111  
COMPLETED     0     0     73     54  
NOT COMPLETED     0     0     43     57  
Adverse Event                 0                 0                 29                 43  
Physician Decision                 0                 0                 5                 4  
Lost to Follow-up                 0                 0                 3                 1  
Withdrawal by Subject                 0                 0                 3                 3  
Sponsor decision                 0                 0                 2                 3  
Non-compliance                 0                 0                 1                 1  
Study medication stopped > 14 days                 0                 0                 0                 1  
Death                 0                 0                 0                 1  



  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
Induction Phase: Cyclophosphamide Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
Induction Phase: Mycophenolate Mofetil Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
Maintenance Phase: Mycophenolate Mofetil Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
Maintenance Phase: Azathioprine Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
Total Total of all reporting groups

Baseline Measures
    Induction Phase: Cyclophosphamide     Induction Phase: Mycophenolate Mofetil     Maintenance Phase: Mycophenolate Mofetil     Maintenance Phase: Azathioprine     Total  
Number of Participants  
[units: participants]
  185     185     116     111     597  
Age, Customized  
[units: years]
Mean ± Standard Deviation
         
Induction Phase     31.3  ± 10.25     32.4  ± 11.7     NA  ± NA [1]   NA  ± NA [1]   31.9  ± 10.72  
Maintenance Phase     NA  ± NA [2]   NA  ± NA [2]   31.8  ± 10.59     31.0  ± 10.77     31.4  ± 10.65  
Gender, Customized  
[units: Participants]
         
Induction Phase - Female     156     157     0     0     313  
Induction Phase - Male     29     28     0     0     57  
Maintenance Phase - Female     0     0     99     96     195  
Maintenance Phase - Male     0     0     17     15     32  
[1] Did not participate in the Induction Phase. Please see Maintenance Phase.
[2] Did not participate in the Maintenance Phase. Please see Induction Phase.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Induction Phase: Number of Patients Showing Treatment Response   [ Time Frame: 24 weeks ]

2.  Primary:   Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

3.  Secondary:   Induction Phase: Number of Participants Achieving Complete Remission   [ Time Frame: 24 weeks ]

4.  Secondary:   Induction Phase: Change From Baseline to Week 24 in Serum Creatinine   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Induction Phase: Change From Baseline to Week 24 in Serum Albumin   [ Time Frame: Baseline, Week 24 ]

7.  Secondary:   Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score   [ Time Frame: Baseline, 24 weeks ]

8.  Secondary:   Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores   [ Time Frame: Baseline and 24 weeks ]

9.  Secondary:   Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

10.  Secondary:   Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

11.  Secondary:   Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

12.  Secondary:   Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

13.  Secondary:   Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]

14.  Secondary:   Maintenance Phase: Participants With Major Extra-renal Flare   [ Time Frame: From the start of the Maintenance Phase to Month 36 ]


  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
For many of the Maintenance Phase Outcomes, the total number of events precluded a meaningful time to event statistical analysis, therefore, only events numbers are reported.


  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


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377637     History of Changes
Obsolete Identifiers: NCT00121082
Other Study ID Numbers: WX17801
Study First Received: September 15, 2006
Results First Received: August 11, 2011
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration