A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis (LUNAR)

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ClinicalTrials.gov Identifier: NCT00282347

Recruitment Status : Completed

First Posted : January 26, 2006

Results First Posted : February 23, 2010

Last Update Posted : January 15, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Genentech, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Lupus Nephritis
Interventions	Drug: Rituximab Drug: Placebo Drug: Mycophenolate mofetil Drug: Methylprednisolone Drug: Diphenhydramine Drug: Acetaminophen Drug: Prednisone
Enrollment	144

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Rituximab	Placebo
Arm/Group Description	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Period Title: Treatment Period
Started	72	72
Completed	67	63
Not Completed	5	9
Reason Not Completed
Death	2	0
Lost to Follow-up	2	5
Withdrawal by Subject	1	3
Physician Decision	0	1
Period Title: Safety Follow-up Period
Started	67	63
Completed	64	57
Not Completed	3	6
Reason Not Completed
Lost to Follow-up	0	2
Withdrawal by Subject	2	1
Physician Decision	1	1
Protocol Deviation	0	2
Period Title: B Cell Follow-up Period
Started	20	4
Completed	15	4
Not Completed	5	0
Reason Not Completed
Withdrawal by Subject	2	0
Physician Decision	1	0
Reason Not Specified	2	0

Baseline Characteristics

Arm/Group Title		Rituximab	Placebo	Total
Arm/Group Description		Participants received rituximab 100...	Participants received placebo intra...	Total of all reporting groups
Arm/Group Description		Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Total of all reporting groups
Overall Number of Baseline Participants		72	72	144
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	72 participants	72 participants	144 participants
< 18 years		2	1	3
18 to < 35 years		48	48	96
35 to < 50 years		18	19	37
≥ 50 years		4	4	8
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	72 participants	72 participants	144 participants
		31.8 (9.6)	29.4 (9.3)	30.6 (9.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	72 participants	72 participants	144 participants
	Female	63 87.5%	67 93.1%	130 90.3%
	Male	9 12.5%	5 6.9%	14 9.7%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
Description	A participant had a CRR if they met the following 3 criteria: (1) Norm...
Description	A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Measure Type: Number Unit of Measure: Percentage of participants
CRR	26.4	30.6
PRR	30.6	15.3
NRR	43.1	54.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5538
	Comments	[Not Specified]
	Method	Stratified Wilcoxon-Rank Sum Test
	Comments	[Not Specified]

2.Secondary Outcome


Title	Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
Description	A participant had a complete renal response if they met the following ...
Description	A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.
Time Frame	Week 24 to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Measure Type: Number Unit of Measure: Percentage of participants
	1.4	6.9

3.Secondary Outcome


Title	Percentage of Participants Who Achieved a Complete Renal Response at Week 52
Description	A participant had a complete renal response if they met the following ...
Description	A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Measure Type: Number Unit of Measure: Percentage of participants
	26.4	30.6

4.Secondary Outcome


Title	Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	38	41
Measure Type: Number Unit of Measure: Percentage of participants
	47.4	53.7

5.Secondary Outcome


Title	British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
Description	The BILAG Index assesses 86 clinical signs and symptoms and laboratory...
Description	The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Mean (Standard Deviation) Unit of Measure: Units on a scale
	-8.49 (5.79)	-8.58 (5.14)

6.Secondary Outcome


Title	Time to Achieve a Complete Renal Response
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Median (95% Confidence Interval) Unit of Measure: Weeks
	11.99 ^[1] (8.31 to NA)	12.12 (9.26 to 13.47)

[1]

The upper limit of the confidence interval could not be estimated due to too few events.

7.Secondary Outcome


Title	Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
Description	The systemic lupus erythematosus Expanded Health Survey is based on th...
Description	The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Mean (Standard Deviation) Unit of Measure: Units on a scale
	4.8 (10.4)	5.7 (9.4)

8.Secondary Outcome


Title	Change From Baseline in Anti-double-stranded DNA at Week 52
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Mean (Standard Deviation) Unit of Measure: IU/mL
	0.45 (0.35)	1.06 (2.19)

9.Secondary Outcome


Title	Change From Baseline in C3 and C4 Complement Levels at Week 52
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).


Arm/Group Title	Rituximab	Placebo
Arm/Group Description:	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description:	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed	72	72
Mean (Standard Deviation) Unit of Measure: mg/dL
C3 Complement	37.5 (28.7)	25.9 (32.5)
C4 Complement	9.9 (7.5)	6.6 (8.9)

Adverse Events

Time Frame	Baseline to the end of the study (up to 7 years)
Adverse Event Reporting Description	Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo). Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.

Arm/Group Title	Rituximab - Treatment and Safety Follow-up Periods	Placebo - Treatment and Safety Follow-up Periods	Rituximab - B Cell Follow-up Period	Placebo - B Cell Follow-up Period
Arm/Group Description	Participants received rituximab 100...	Participants received placebo intra...	Participants received rituximab 100...	Participants received placebo intra...
Arm/Group Description	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.	Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
All-Cause Mortality
	Rituximab - Treatment and Safety Follow-up Periods	Placebo - Treatment and Safety Follow-up Periods	Rituximab - B Cell Follow-up Period	Placebo - B Cell Follow-up Period
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Rituximab - Treatment and Safety Follow-up Periods	Placebo - Treatment and Safety Follow-up Periods	Rituximab - B Cell Follow-up Period	Placebo - B Cell Follow-up Period
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/73 (32.88%)	29/71 (40.85%)	3/20 (15.00%)	0/4 (0.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/73 (4.11%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
Leukopenia ^† 1	2/73 (2.74%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Neutropenia ^† 1	2/73 (2.74%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Coagulopathy ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Disseminated Intravascular Coagulation ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Febrile Neutropenia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Haemolytic Anaemia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Nephrogenic anemia ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Cardiac disorders
Atrial Fibrillation ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Myocardial Infarction ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Pericardial Effusion ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Pericarditis ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Endocrine disorders
Thyroiditis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Gastrointestinal disorders
Nausea ^† 1	1/73 (1.37%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Abdominal Pain ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Ascites ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Diarrhoea ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Gastrointestinal Haemorrhage ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Haemorrhoids ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Lower Gastrointestinal Haemorrhage ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
General disorders
Chest Pain ^† 1	0/73 (0.00%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Drug Intolerance ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Generalized Oedema ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Oedema ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Immune system disorders
Antiphospholipid Syndrome ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Infections and infestations
Pneumonia ^† 1	2/73 (2.74%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
Cellulitis ^† 1	2/73 (2.74%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Herpes Zoster ^† 1	1/73 (1.37%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Bronchopneumonia ^† 1	1/73 (1.37%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Gastroenteritis ^† 1	0/73 (0.00%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Urinary Tract Infection ^† 1	1/73 (1.37%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Bacteraemia ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Bacterial Infection ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Bronchitis ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Catheter Related Infection ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Cytomegalovirus Colitis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Fungal Sepsis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Gastroenteritis Viral ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Genital Herpes ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Histoplasmosis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Impetigo ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Lobar Pneumonia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Pneumonia Cryptococcal ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Pneumonia Cytomegaloviral ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Sepsis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Sinusitis ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Soft Tissue Infection ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Subcutaneous Abscess ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Upper Respiratory Tract Infection ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Wound Infection ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Investigations
International Normalized Ratio Decreased ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Metabolism and nutrition disorders
Diabetes Mellitus ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Hypoalbuminaemia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus ^† 1	0/73 (0.00%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Arthralgia ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Pain in Extremity ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Breast cancer ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Nervous system disorders
Convulsion ^† 1	0/73 (0.00%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Vasculitis Cerebral ^† 1	1/73 (1.37%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Cerebral Ischaemia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Hypersensitive Encephalopathy ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Ruptured Cerebral Aneurysm ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Syncope ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Abortion Spontaneous ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Psychiatric disorders
Depression ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Psychotic Disorder ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Renal and urinary disorders
Renal Failure Acute ^† 1	1/73 (1.37%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
Azotaemia ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Renal Failure ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Pyelonephritis ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis ^† 1	2/73 (2.74%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Pleural Effusion ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Pleurisy ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Pulmonary Embolism ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Respiratory Failure ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Skin and subcutaneous tissue disorders
Rash Vesicular ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Urticaria ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Surgical and medical procedures
Renal transplant ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Vascular disorders
Hypertension ^† 1	0/73 (0.00%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Deep Vein Thrombosis ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Hypotension ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Malignant Hypertension ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Thrombosis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Vasculitis ^† 1	0/73 (0.00%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Vena Cava Thrombosis ^† 1	1/73 (1.37%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rituximab - Treatment and Safety Follow-up Periods	Placebo - Treatment and Safety Follow-up Periods	Rituximab - B Cell Follow-up Period	Placebo - B Cell Follow-up Period
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	69/73 (94.52%)	66/71 (92.96%)	8/20 (40.00%)	0/4 (0.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	10/73 (13.70%)	9/71 (12.68%)	0/20 (0.00%)	0/4 (0.00%)
Leukopenia ^† 1	7/73 (9.59%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Cardiac disorders
Tachycardia ^† 1	6/73 (8.22%)	5/71 (7.04%)	0/20 (0.00%)	0/4 (0.00%)
Palpitations ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Ear and labyrinth disorders
Ear infection ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Endocrine disorders
Cushingoid ^† 1	4/73 (5.48%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Amenorrhoea ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Eye disorders
Conjunctivitis ^† 1	3/73 (4.11%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Vision Blurred ^† 1	3/73 (4.11%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	28/73 (38.36%)	28/71 (39.44%)	0/20 (0.00%)	0/4 (0.00%)
Nausea ^† 1	20/73 (27.40%)	21/71 (29.58%)	0/20 (0.00%)	0/4 (0.00%)
Vomiting ^† 1	19/73 (26.03%)	14/71 (19.72%)	0/20 (0.00%)	0/4 (0.00%)
Dyspepsia ^† 1	5/73 (6.85%)	9/71 (12.68%)	0/20 (0.00%)	0/4 (0.00%)
Gastroesophageal Reflux Disease ^† 1	2/73 (2.74%)	7/71 (9.86%)	0/20 (0.00%)	0/4 (0.00%)
Abdominal Distension ^† 1	4/73 (5.48%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Abdominal Pain Upper ^† 1	4/73 (5.48%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Abdominal Pain ^† 1	3/73 (4.11%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Abdominal Discomfort ^† 1	4/73 (5.48%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Dental Caries ^† 1	4/73 (5.48%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
Haemorrhoids ^† 1	4/73 (5.48%)	2/71 (2.82%)	0/20 (0.00%)	0/4 (0.00%)
General disorders
Oedema Peripheral ^† 1	6/73 (8.22%)	11/71 (15.49%)	0/20 (0.00%)	0/4 (0.00%)
Oedema ^† 1	8/73 (10.96%)	7/71 (9.86%)	0/20 (0.00%)	0/4 (0.00%)
Chest Pain ^† 1	4/73 (5.48%)	10/71 (14.08%)	0/20 (0.00%)	0/4 (0.00%)
Pyrexia ^† 1	9/73 (12.33%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Chills ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Pain ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Fatigue ^† 1	12/73 (16.44%)	9/71 (12.68%)	0/20 (0.00%)	0/4 (0.00%)
Immune system disorders
Seasonal Allergy ^† 1	5/73 (6.85%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Infections and infestations
Upper Respiratory Tract Infection ^† 1	21/73 (28.77%)	23/71 (32.39%)	1/20 (5.00%)	0/4 (0.00%)
Urinary Tract Infection ^† 1	17/73 (23.29%)	20/71 (28.17%)	3/20 (15.00%)	0/4 (0.00%)
Herpes Zoster ^† 1	11/73 (15.07%)	8/71 (11.27%)	0/20 (0.00%)	0/4 (0.00%)
Gastroenteritis ^† 1	8/73 (10.96%)	7/71 (9.86%)	0/20 (0.00%)	0/4 (0.00%)
Nasopharyngitis ^† 1	8/73 (10.96%)	5/71 (7.04%)	1/20 (5.00%)	0/4 (0.00%)
Sinusitis ^† 1	9/73 (12.33%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Bronchitis ^† 1	6/73 (8.22%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Oral Candidiasis ^† 1	6/73 (8.22%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Candidiasis ^† 1	4/73 (5.48%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
Cellulitis ^† 1	3/73 (4.11%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Influenza ^† 1	3/73 (4.11%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Gastroenteritis Viral ^† 1	1/73 (1.37%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Peritonitis bacterial ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Fungal skin infection ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Injury, poisoning and procedural complications
Contusion ^† 1	5/73 (6.85%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Investigations
Blood Potassium Decreased ^† 1	1/73 (1.37%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Glomerular filtration rate decreased ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Blood creatinine increased ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	10/73 (13.70%)	10/71 (14.08%)	0/20 (0.00%)	0/4 (0.00%)
Hypercholesterolaemia ^† 1	8/73 (10.96%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
Musculoskeletal and connective tissue disorders
Muscle Spasms ^† 1	17/73 (23.29%)	18/71 (25.35%)	0/20 (0.00%)	0/4 (0.00%)
Arthralgia ^† 1	16/73 (21.92%)	16/71 (22.54%)	0/20 (0.00%)	0/4 (0.00%)
Pain in Extremity ^† 1	9/73 (12.33%)	9/71 (12.68%)	0/20 (0.00%)	0/4 (0.00%)
Back Pain ^† 1	6/73 (8.22%)	11/71 (15.49%)	0/20 (0.00%)	0/4 (0.00%)
Neck Pain ^† 1	6/73 (8.22%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Myalgia ^† 1	3/73 (4.11%)	6/71 (8.45%)	0/20 (0.00%)	0/4 (0.00%)
Musculoskeletal Chest Pain ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Nervous system disorders
Headache ^† 1	26/73 (35.62%)	19/71 (26.76%)	0/20 (0.00%)	0/4 (0.00%)
Dizziness ^† 1	9/73 (12.33%)	5/71 (7.04%)	0/20 (0.00%)	0/4 (0.00%)
Tremor ^† 1	3/73 (4.11%)	5/71 (7.04%)	0/20 (0.00%)	0/4 (0.00%)
Dysgeusia ^† 1	2/73 (2.74%)	5/71 (7.04%)	0/20 (0.00%)	0/4 (0.00%)
Hypoaesthesia ^† 1	1/73 (1.37%)	5/71 (7.04%)	0/20 (0.00%)	0/4 (0.00%)
Psychiatric disorders
Insomnia ^† 1	10/73 (13.70%)	14/71 (19.72%)	0/20 (0.00%)	0/4 (0.00%)
Anxiety ^† 1	5/73 (6.85%)	8/71 (11.27%)	0/20 (0.00%)	0/4 (0.00%)
Depression ^† 1	5/73 (6.85%)	6/71 (8.45%)	0/20 (0.00%)	0/4 (0.00%)
Renal and urinary disorders
Pyelonephritis ^† 1	0/73 (0.00%)	0/71 (0.00%)	1/20 (5.00%)	0/4 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	16/73 (21.92%)	13/71 (18.31%)	0/20 (0.00%)	0/4 (0.00%)
Dyspnoea ^† 1	5/73 (6.85%)	7/71 (9.86%)	0/20 (0.00%)	0/4 (0.00%)
Epistaxis ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Oropharyngeal Pain ^† 1	2/73 (2.74%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Pleuritic Pain ^† 1	1/73 (1.37%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Rhinorrhoea ^† 1	0/73 (0.00%)	4/71 (5.63%)	0/20 (0.00%)	0/4 (0.00%)
Throat Irritation ^† 1	4/73 (5.48%)	0/71 (0.00%)	0/20 (0.00%)	0/4 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	10/73 (13.70%)	6/71 (8.45%)	0/20 (0.00%)	0/4 (0.00%)
Rash ^† 1	7/73 (9.59%)	8/71 (11.27%)	0/20 (0.00%)	0/4 (0.00%)
Acne ^† 1	3/73 (4.11%)	8/71 (11.27%)	0/20 (0.00%)	0/4 (0.00%)
Swelling Face ^† 1	4/73 (5.48%)	1/71 (1.41%)	0/20 (0.00%)	0/4 (0.00%)
Vascular disorders
Hypertension ^† 1	7/73 (9.59%)	7/71 (9.86%)	0/20 (0.00%)	0/4 (0.00%)
Hypotension ^† 1	8/73 (10.96%)	3/71 (4.23%)	0/20 (0.00%)	0/4 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)

Limitations and Caveats

[Not Specified]

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 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.

Results Point of Contact

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Name/Title:	Medical Communications
Organization:	Genentech, Inc.
Phone:	800-821-8590

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gomez Mendez LM, Cascino MD, Garg J, Katsumoto TR, Brakeman P, Dall'Era M, Looney RJ, Rovin B, Dragone L, Brunetta P. Peripheral Blood B Cell Depletion after Rituximab and Complete Response in Lupus Nephritis. Clin J Am Soc Nephrol. 2018 Oct 8;13(10):1502-1509. doi: 10.2215/CJN.01070118. Epub 2018 Aug 8. Erratum In: Clin J Am Soc Nephrol. 2019 Jan 7;14(1):111.

Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.

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.

Layout table for additonal information

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00282347
Other Study ID Numbers:	U2970g
First Submitted:	January 24, 2006
First Posted:	January 26, 2006
Results First Submitted:	February 1, 2010
Results First Posted:	February 23, 2010
Last Update Posted:	January 15, 2015

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