Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00423098
First received: January 16, 2007
Last updated: May 31, 2011
Last verified: May 2011
Results First Received: December 14, 2010  
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 sodium
Drug: Prednisone
Drug: Methylprednisolone

  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 Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Low Dose Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.

Participant Flow:   Overall Study
    Standard Dose     Low Dose  
STARTED     42 [1]   39  
COMPLETED     39 [2]   35  
NOT COMPLETED     3     4  
Adverse Event                 1                 2  
Unsatisfactory therapeutic effect                 0                 1  
Administrative problems                 0                 1  
Death                 2                 0  
[1] Total number of patients screened was 90, but the total number of randomized patients was 81.
[2] Completed 24 weeks of study medication.



  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.
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Reporting Groups
  Description
Standard Dose Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Low Dose Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Standard Dose     Low Dose     Total  
Number of Participants  
[units: participants]
  42     39     81  
Age  
[units: years]
Mean ± Standard Deviation
  32.2  ± 8.53     34.2  ± 10.74     33.1  ± 9.65  
Age, Customized  
[units: participants]
     
18-29 years     20     18     38  
30-39 years     16     10     26  
40-49 years     4     6     10  
50-59 years     2     4     6  
>=60 years     0     1     1  
Gender  
[units: participants]
     
Female     37     29     66  
Male     5     10     15  



  Outcome Measures
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1.  Primary:   Number of Patients With Complete Remission   [ Time Frame: 24 Weeks ]

2.  Secondary:   Number of Patients With Complete Remission   [ Time Frame: 12 Weeks ]

3.  Secondary:   Number of Patients With Partial Remission   [ Time Frame: Baseline to 12 and 24 weeks ]

4.  Secondary:   Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)   [ Time Frame: 12 Weeks and 24 Weeks ]

5.  Secondary:   Number of Patients With Moderate to Severe Flares   [ Time Frame: 12 and 24 weeks ]

6.  Secondary:   Duration of Exposure to Study Medication   [ Time Frame: 24 weeks ]

7.  Secondary:   Number of Patients With Adverse Events and Infections   [ Time Frame: 24 weeks ]

8.  Secondary:   Number of Patients With Treatment Failure   [ Time Frame: 12 Weeks and 24 Weeks ]

9.  Secondary:   Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)   [ Time Frame: From Baseline to week 4, week 12 and week 24 ]

10.  Secondary:   Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)   [ Time Frame: From Baseline to week 4, week 12 and week 24 ]


  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: NCT00423098     History of Changes
Other Study ID Numbers: CERL080A2420
Study First Received: January 16, 2007
Results First Received: December 14, 2010
Last Updated: May 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)