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 ]

Show Outcome Measure 9

Serious Adverse Events

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Other Adverse Events

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Time Frame	78 weeks
Additional Description	Safety analysis population

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Rituximab	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	69/73	66/71
Blood and lymphatic system disorders
Anaemia ^†
# participants affected / at risk	10/73 (13.70%)	9/71 (12.68%)
Leukopenia ^†
# participants affected / at risk	7/73 (9.59%)	2/71 (2.82%)
Cardiac disorders
Tachycardia ^†
# participants affected / at risk	6/73 (8.22%)	5/71 (7.04%)
Palpitations ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Endocrine disorders
Cushingoid ^†
# participants affected / at risk	4/73 (5.48%)	2/71 (2.82%)
Eye disorders
Conjunctivitis ^†
# participants affected / at risk	3/73 (4.11%)	4/71 (5.63%)
Vision Blurred ^†
# participants affected / at risk	3/73 (4.11%)	4/71 (5.63%)
Gastrointestinal disorders
Diarrhoea ^†
# participants affected / at risk	28/73 (38.36%)	28/71 (39.44%)
Nausea ^†
# participants affected / at risk	20/73 (27.40%)	21/71 (29.58%)
Vomiting ^†
# participants affected / at risk	19/73 (26.03%)	14/71 (19.72%)
Dyspepsia ^†
# participants affected / at risk	5/73 (6.85%)	9/71 (12.68%)
Gastroesophageal Reflux Disease ^†
# participants affected / at risk	2/73 (2.74%)	7/71 (9.86%)
Abdominal Distension ^†
# participants affected / at risk	4/73 (5.48%)	4/71 (5.63%)
Abdominal Pain Upper ^†
# participants affected / at risk	4/73 (5.48%)	4/71 (5.63%)
Abdominal Pain ^†
# participants affected / at risk	3/73 (4.11%)	4/71 (5.63%)
Abdominal Discomfort ^†
# participants affected / at risk	4/73 (5.48%)	2/71 (2.82%)
Dental Caries ^†
# participants affected / at risk	4/73 (5.48%)	2/71 (2.82%)
Haemorrhoids ^†
# participants affected / at risk	4/73 (5.48%)	2/71 (2.82%)
General disorders
Oedema Peripheral ^†
# participants affected / at risk	6/73 (8.22%)	11/71 (15.49%)
Oedema ^†
# participants affected / at risk	8/73 (10.96%)	7/71 (9.86%)
Chest Pain ^†
# participants affected / at risk	4/73 (5.48%)	10/71 (14.08%)
Pyrexia ^†
# participants affected / at risk	9/73 (12.33%)	4/71 (5.63%)
Chills ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Pain ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Fatigue ^†
# participants affected / at risk	12/73 (16.44%)	9/71 (12.68%)
Immune system disorders
Seasonal Allergy ^†
# participants affected / at risk	5/73 (6.85%)	0/71 (0.00%)
Infections and infestations
Upper Respiratory Tract Infection ^†
# participants affected / at risk	21/73 (28.77%)	23/71 (32.39%)
Urinary Tract Infection ^†
# participants affected / at risk	17/73 (23.29%)	20/71 (28.17%)
Herpes Zoster ^†
# participants affected / at risk	11/73 (15.07%)	8/71 (11.27%)
Gastroenteritis ^†
# participants affected / at risk	8/73 (10.96%)	7/71 (9.86%)
Nasopharyngitis ^†
# participants affected / at risk	8/73 (10.96%)	5/71 (7.04%)
Sinusitis ^†
# participants affected / at risk	9/73 (12.33%)	4/71 (5.63%)
Bronchitis ^†
# participants affected / at risk	6/73 (8.22%)	4/71 (5.63%)
Oral Candidiasis ^†
# participants affected / at risk	6/73 (8.22%)	4/71 (5.63%)
Candidiasis ^†
# participants affected / at risk	4/73 (5.48%)	3/71 (4.23%)
Cellulitis ^†
# participants affected / at risk	3/73 (4.11%)	4/71 (5.63%)
Influenza ^†
# participants affected / at risk	3/73 (4.11%)	4/71 (5.63%)
Gastroenteritis Viral ^†
# participants affected / at risk	1/73 (1.37%)	4/71 (5.63%)
Injury, poisoning and procedural complications
Contusion ^†
# participants affected / at risk	5/73 (6.85%)	1/71 (1.41%)
Investigations
Blood Potassium Decreased ^†
# participants affected / at risk	1/73 (1.37%)	4/71 (5.63%)
Metabolism and nutrition disorders
Hypokalaemia ^†
# participants affected / at risk	10/73 (13.70%)	10/71 (14.08%)
Hypercholesterolaemia ^†
# participants affected / at risk	8/73 (10.96%)	3/71 (4.23%)
Musculoskeletal and connective tissue disorders
Muscle Spasms ^†
# participants affected / at risk	17/73 (23.29%)	18/71 (25.35%)
Arthralgia ^†
# participants affected / at risk	16/73 (21.92%)	16/71 (22.54%)
Pain in Extremity ^†
# participants affected / at risk	9/73 (12.33%)	9/71 (12.68%)
Back Pain ^†
# participants affected / at risk	6/73 (8.22%)	11/71 (15.49%)
Neck Pain ^†
# participants affected / at risk	6/73 (8.22%)	4/71 (5.63%)
Myalgia ^†
# participants affected / at risk	3/73 (4.11%)	6/71 (8.45%)
Musculoskeletal Chest Pain ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Nervous system disorders
Headache ^†
# participants affected / at risk	26/73 (35.62%)	19/71 (26.76%)
Dizziness ^†
# participants affected / at risk	9/73 (12.33%)	5/71 (7.04%)
Tremor ^†
# participants affected / at risk	3/73 (4.11%)	5/71 (7.04%)
Dysgeusia ^†
# participants affected / at risk	2/73 (2.74%)	5/71 (7.04%)
Hypoaesthesia ^†
# participants affected / at risk	1/73 (1.37%)	5/71 (7.04%)
Psychiatric disorders
Insomnia ^†
# participants affected / at risk	10/73 (13.70%)	14/71 (19.72%)
Anxiety ^†
# participants affected / at risk	5/73 (6.85%)	8/71 (11.27%)
Depression ^†
# participants affected / at risk	5/73 (6.85%)	6/71 (8.45%)
Respiratory, thoracic and mediastinal disorders
Cough ^†
# participants affected / at risk	16/73 (21.92%)	13/71 (18.31%)
Dyspnoea ^†
# participants affected / at risk	5/73 (6.85%)	7/71 (9.86%)
Epistaxis ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Oropharyngeal Pain ^†
# participants affected / at risk	2/73 (2.74%)	4/71 (5.63%)
Pleuritic Pain ^†
# participants affected / at risk	1/73 (1.37%)	4/71 (5.63%)
Rhinorrhoea ^†
# participants affected / at risk	0/73 (0.00%)	4/71 (5.63%)
Throat Irritation ^†
# participants affected / at risk	4/73 (5.48%)	0/71 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^†
# participants affected / at risk	10/73 (13.70%)	6/71 (8.45%)
Rash ^†
# participants affected / at risk	7/73 (9.59%)	8/71 (11.27%)
Acne ^†
# participants affected / at risk	3/73 (4.11%)	8/71 (11.27%)
Swelling Face ^†
# participants affected / at risk	4/73 (5.48%)	1/71 (1.41%)
Vascular disorders
Hypertension ^†
# participants affected / at risk	7/73 (9.59%)	7/71 (9.86%)
Hypotension ^†
# participants affected / at risk	8/73 (10.96%)	3/71 (4.23%)

†	Events were collected by systematic assessment

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:

	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
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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:

Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, Maciuca R, Zhang D, Garg JP, Brunetta P, Appel G; LUNAR Investigator Group. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012 Apr;64(4):1215-26. doi: 10.1002/art.34359. Epub 2012 Jan 9.

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

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