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.

Study NCT00282347 Information provided by Genentech

First Received on January 24, 2006. Last Updated on April 14, 2011 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

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
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

Hide Baseline Characteristics

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

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

Show All Outcome Measures

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 ]

Show Outcome Measure 5

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

Show Serious Adverse Events

Other Adverse Events

Show 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

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

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
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:	April 14, 2011
Health Authority:	United States: Food and Drug Administration