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

This study has been terminated.
(Study was terminated early for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00425438
First received: January 22, 2007
Last updated: September 22, 2014
Last verified: September 2014
Results First Received: August 14, 2014  
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
Drug: Corticosteroids
Drug: Azathioprine
Drug: Cyclophosphamide

  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
Mycophenolate Mofetil Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
Cyclophosphamide, Azathioprine Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.

Participant Flow:   Overall Study
    Mycophenolate Mofetil     Cyclophosphamide, Azathioprine  
STARTED     25     27  
COMPLETED     0     0  
NOT COMPLETED     25     27  
Termination by Sponsor                 25                 27  



  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.
Safety population: all participants who recieved at least one dose of study drug.

Reporting Groups
  Description
Mycophenolate Mofetil Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
Cyclophosphamide, Azathioprine Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
Total Total of all reporting groups

Baseline Measures
    Mycophenolate Mofetil     Cyclophosphamide, Azathioprine     Total  
Number of Participants  
[units: participants]
  25     27     52  
Age  
[units: years]
Mean ± Standard Deviation
  33.4  ± 9.8     31.6  ± 8.0     32.4  ± 8.9  
Gender  
[units: participants]
     
Female     22     23     45  
Male     3     4     7  



  Outcome Measures
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1.  Primary:   Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]

2.  Secondary:   Complete Response   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]

3.  Secondary:   Percentage of Participants With Treatment Response Event by End of Treatment   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]

4.  Secondary:   Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]

5.  Secondary:   Percentage of Participants Terminating Treatment   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]

6.  Secondary:   Time to Treatment Failure   [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ]


  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
The study was terminated early due to administrative reasons.


  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
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00425438     History of Changes
Other Study ID Numbers: ML19978
Study First Received: January 22, 2007
Results First Received: August 14, 2014
Last Updated: September 22, 2014
Health Authority: China: Food and Drug Administration