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A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis (LUNAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00282347
First received: January 24, 2006
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
Results First Received: February 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Lupus Nephritis
Interventions: Drug: corticosteroids
Drug: methylprednisolone
Drug: mycophenolate mofetil
Drug: placebo
Drug: rituximab

  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
No text entered.

Reporting Groups
  Description
Rituximab Rituximab intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone
Placebo Placebo intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone

Participant Flow for 2 periods

 Period 1:   52 Weeks
    Rituximab     Placebo  
STARTED     72     72  
COMPLETED     67     63  
NOT COMPLETED     5     9  
Death                 2                 0  
Lost to Follow-up                 2                 5  
Withdrawal by Subject                 1                 3  
Physician Decision                 0                 1  

Period 2:   78 Weeks
    Rituximab     Placebo  
STARTED     72     72  
COMPLETED     64     57  
NOT COMPLETED     8     15  
Death                 2                 0  
Withdrawal by Subject                 3                 4  
Lost to Follow-up                 2                 7  
Physician Decision                 1                 2  
Protocol deviation                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Rituximab Rituximab intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone
Placebo Placebo intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone
Total Total of all reporting groups

Baseline Measures
    Rituximab     Placebo     Total  
Number of Participants  
[units: participants]
 		  72     72     144  
Age, Customized  
[units: participants]
 		     
<18 years     2     1     3  
18 -- <35 years     48     48     96  
35 -- <50 years     18     19     37  
>=50 years     4     4     8  
Age  
[units: years]
Mean ± Standard Deviation 		  31.8  ± 9.6     29.4  ± 9.3     30.6  ± 9.5  
Gender  
[units: participants]
 		     
Female     63     67     130  
Male     9     5     14  



  Outcome Measures
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1.  Primary:   Proportion of Subjects Who Achieve a Renal Response   [ Time Frame: 52 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change in C3 and C4 Complement Levels From Baseline   [ Time Frame: 52 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Proportion of Subjects Who Achieve a Complete Renal Response   [ Time Frame: 52 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Proportion of Subjects With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieve a Urine Protein to Creatinine Ratio of < 1.0   [ Time Frame: 52 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Time-adjusted Area Under the Concentration-time Curve Minus Baseline Area Under the Concentration–Time Curve Minus Baseline(AUCMB) of BILAG Global Score   [ Time Frame: 52 weeks ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Time-adjusted Area Under the Concentration-time Curve Minus Baseline Area Under the Concentration–Time Curve Minus Baseline(AUCMB) of BILAG Global Score
Measure Description

A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks is calculated as:

  1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks.
  2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study.
  3. Minus the Time-Adjusted AUC by the baseline BILAG global score
Time Frame 52 weeks  
Safety Issue No  

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.
Intent-to-Treat Population

Reporting Groups
  Description
Rituximab Rituximab intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone
Placebo Placebo intravenously at a dose of 1000 mg on Days 1, 15, 168, and 182, mycophenolate mofetil intravenously at a dose of 1500 mg/day given in three divided doses and titrated up to 3000 mg/day by Week 4 and increased by 500 mg/week as tolerated, corticosteroids, methylprednisolone

Measured Values
    Rituximab     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  72     72  
Time-adjusted Area Under the Concentration-time Curve Minus Baseline Area Under the Concentration–Time Curve Minus Baseline(AUCMB) of BILAG Global Score  
[units: score]
Mean ( 95% Confidence Interval ) 		  -8.49  
  ( -9.87 to -7.11 )   		  -8.58  
  ( -9.80 to -7.35 )  

No statistical analysis provided for Time-adjusted Area Under the Concentration-time Curve Minus Baseline Area Under the Concentration–Time Curve Minus Baseline(AUCMB) of BILAG Global Score



6.  Secondary:   Time to Complete Renal Response   [ Time Frame: 52 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change in SLE Expanded Health Survey Physical Function Score   [ Time Frame: 52 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change in Anti-double Stranded DNA From Baseline   [ Time Frame: 52 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52   [ Time Frame: Week 52 ]
  Show Outcome Measure 9


  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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590


No publications provided by Genentech

Publications automatically indexed to this study:


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00282347     History of Changes
Other Study ID Numbers: U2970g
Study First Received: January 24, 2006
Results First Received: February 1, 2010
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration