Trial · NCT04221477

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

NCT04221477, Phase 3, Active not recruiting, Hoffmann-La Roche; results first posted 2025-11-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis. Trials, record NCT04221477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04221477

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT number: NCT04221477
Status: Active not recruiting
Phases: Phase 3
Enrollment: 271 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Lupus Nephritis
Interventions: Obinutuzumab, MMF, Prednisone, Placebo, Methylprednisolone, Acetaminophen, Diphenhydramine
First posted: 2020-01-09
Last updated: 2026-10-19
Other registries' IDs: eudract:2019-004034-42
Results first posted: 2025-11-06

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Complete Renal Response (CRR)	At Week 76	CRR was defined as an achievement of all the following criteria: urinary protein-to-creatinine ratio (UPCR) \<0.5 gram/gram (g/g); estimated glomerular filtration rate (eGFR) \>=85% of baseline, as calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Obinutuzumab and placebo were compared using Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using fully conditional specification (FCS) predicted mean matching method. Percentage have been rounded off.
Secondary	Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76	At Week 76	CRR with successful prednisone was defined as the achievement of CRR at Week 76 with no receipt of prednisone \>7.5 milligrams per day (mg/day) (or equivalent) from Week 64 through Week 76. CRR was defined as achievement of all the following criteria: UPCR \<0.5 g/g; eGFR \>=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.
Secondary	Percentage of Participants Who Achieve a Proteinuric Response	At Week 76	Proteinuric response was defined as an achievement of all the following criteria: UPCR \<0.8 g/g and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.
Secondary	Mean Change in eGFR	At Week 76	Change in eGFR from baseline to Week 76 was analyzed using Analysis of Covariance (ANCOVA) model with covariates baseline eGFR and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. mL/min/1.73 m\^2 = milliliters per minute per 1.73 square meters. Adjusted mean has been reported.
Secondary	Percentage of Participants Who Experience Death or Renal-related Events	From Day 1 to Week 76	Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value \<60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off.
Secondary	Percentage of Participants Who Achieve an Overall Renal Response (ORR)	At Week 50	ORR was defined as achievement of either CRR or PRR. CRR was defined as achievement of all of the criteria: UPCR \<0.5 g/g; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation. PRR was defined as achievement of all of the following criteria: ≥50% reduction in UPCR from baseline; UPCR \<1 g/g (or \<3 g/g if the baseline UPCR was ≥3 g/g); eGFR ≥85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.
Secondary	Change From Baseline in Fatigue Assessed Using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale	At Week 76	The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-F score of 0 (worse score) to 52 (better score). Higher scores indicate less fatigue. Change in FACIT-F score from baseline at Week 76 was analyzed using ANCOVA model with covariates baseline FACIT-F score and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing FACIT-F score after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.
Secondary	Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer	At Week 50	Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter \[IU/mL\]). Adjusted mean has been reported.
Secondary	Change in Complement C3	At Week 50	C3 is a marker of inflammation. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with lower limit of quantification (LLOQ)/2 under composite strategy. LLOQ at the central lab was set for C3 at 0.100 grams/liters (g/L). Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.
Secondary	Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	At Week 76	The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Complete Renal Response (CRR)	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieve a Proteinuric Response	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	percentage of participants	NUMBER
SECONDARY	Mean Change in eGFR	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	mL/min/1.73 m^2	MEAN
SECONDARY	Percentage of Participants Who Experience Death or Renal-related Events	From Day 1 to Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieve an Overall Renal Response (ORR)	At Week 50	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Fatigue Assessed Using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	score on a scale	MEAN
SECONDARY	Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer	At Week 50	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	Log (IU/mL)	MEAN
SECONDARY	Change in Complement C3	At Week 50	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	g/L	MEAN
SECONDARY	Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	At Week 76	Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.	score on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Complete Renal Response (CRR)	Obinutuzumab	46.4	95% Confidence Interval 37.95 to 54.86	percentage of participants
Percentage of Participants With Complete Renal Response (CRR)	Placebo	33.1	95% Confidence Interval 25.18 to 41.00	percentage of participants
Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76	Obinutuzumab	42.7	95% Confidence Interval 34.32 to 51.09	percentage of participants
Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76	Placebo	30.9	95% Confidence Interval 23.12 to 38.65	percentage of participants
Percentage of Participants Who Achieve a Proteinuric Response	Obinutuzumab	55.5	95% Confidence Interval 47.09 to 63.95	percentage of participants
Percentage of Participants Who Achieve a Proteinuric Response	Placebo	41.9	95% Confidence Interval 33.62 to 50.20	percentage of participants
Mean Change in eGFR	Obinutuzumab	2.31	Standard Error 2.713	mL/min/1.73 m^2
Mean Change in eGFR	Placebo	-1.54	Standard Error 2.706	mL/min/1.73 m^2
Percentage of Participants Who Experience Death or Renal-related Events	Obinutuzumab	18.9	95% Confidence Interval 12.11 to 25.61	percentage of participants
Percentage of Participants Who Experience Death or Renal-related Events	Placebo	35.6	95% Confidence Interval 27.50 to 43.78	percentage of participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Obinutuzumab	135
Overall Study	STARTED	Placebo	136
Overall Study	Safety Population	Obinutuzumab	136
Overall Study	Safety Population	Placebo	132
Overall Study	Completed Week 76 Assessment	Obinutuzumab	122
Overall Study	Completed Week 76 Assessment	Placebo	120
Overall Study	COMPLETED	Obinutuzumab	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Obinutuzumab	135
Overall Study	NOT COMPLETED	Placebo	136

Source ClinicalTrials.gov

Adverse events164

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Obinutuzumab	7	136	7
other	Anaemia	Blood and lymphatic system disorders	Placebo	9	132	10
other	Leukopenia	Blood and lymphatic system disorders	Obinutuzumab	7	136	10
other	Leukopenia	Blood and lymphatic system disorders	Placebo	6	132	8
other	Neutropenia	Blood and lymphatic system disorders	Obinutuzumab	12	136	14
other	Neutropenia	Blood and lymphatic system disorders	Placebo	4	132	5
other	Abdominal pain	Gastrointestinal disorders	Obinutuzumab	4	136	6
other	Abdominal pain	Gastrointestinal disorders	Placebo	10	132	16
other	Diarrhoea	Gastrointestinal disorders	Obinutuzumab	28	136	33
other	Diarrhoea	Gastrointestinal disorders	Placebo	21	132	35

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Obinutuzumab	5	136
Total, all-cause mortality	Placebo	4	132
Total, other adverse events	Obinutuzumab	107	136
Total, other adverse events	Placebo	94	132
Total, serious adverse events	Obinutuzumab	44	136
Total, serious adverse events	Placebo	24	132

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33693991	DERIVED	PubMed
37528520	DERIVED	PubMed
39927615	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Obinutuzumab vs Placebo: Number of Participants With Adverse Events (AEs)	Trial comparisons
Obinutuzumab vs Placebo: deaths from any cause	Trial comparisons
Obinutuzumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04221477

GET https://conductscience.org/api/trials/v1/NCT04221477/results?page=2

API reference For AI assistants