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
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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

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 ]

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2. Secondary:

Change in C3 and C4 Complement Levels From Baseline [ Time Frame: 52 weeks ]

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3. Secondary:

Proportion of Subjects Who Achieve a Complete Renal Response [ Time Frame: 52 weeks ]

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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 ]

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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 ]

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6. Secondary:

Time to Complete Renal Response [ Time Frame: 52 weeks ]

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7. Secondary:

Change in SLE Expanded Health Survey Physical Function Score [ Time Frame: 52 weeks ]

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8. Secondary:

Change in Anti-double Stranded DNA From Baseline [ Time Frame: 52 weeks ]

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9. Secondary:

Number of Subjects Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52 [ Time Frame: Week 52 ]