Trial · NCT01639339

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

NCT01639339, Phase 3, Completed, Human Genome Sciences Inc., a GSK Company; results first posted 2020-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis. Trials, record NCT01639339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01639339

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Trial

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

Title: Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
NCT number: NCT01639339
Status: Completed
Phases: Phase 3
Enrollment: 448 participants, actual
Lead sponsor: Human Genome Sciences Inc., a GSK Company
Conditions: Lupus Nephritis
Interventions: Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
First posted: 2012-07-12
Last updated: 2021-03-19
Other registries' IDs: eudract:2011-004570-28
Results first posted: 2020-07-07

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	Week 104	PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
Primary	Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)	From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Primary	Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)	From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)	An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.
Secondary	Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	Week 104	CRR is defined as urinary protein creatinine ratio \<0.5, eGRF was not more than 10% below the pre-flare value or \>=90 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline uPCR and Baseline eGFR. Percentage of participants with CRR at Week 104 has been presented.
Secondary	Double-blind Period: Percentage of Participants With PERR at Week 52	Week 52	PERR is defined as urinary protein creatinine ratio \<=0.7, eGRF was not more than 20% below the pre-flare value or \>=60 mL/min/1.73m\^2 and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates of induction regimen (CYC vs. MMF), race (Black vs. Non-Black), uPCR, and Baseline eGFR. Percentage of participants with PERR at Week 52 has been presented.
Secondary	Double-blind Period: Number of Participants With Time to Death or Renal Related Event	Up to Week 104	Events are defined as the first event experienced among the following: death, progression to end stage renal disease, doubling of serum creatinine from Baseline, renal worsening or renal-related treatment failure. Participants who discontinued randomized treatment, withdrew from the study, were lost to follow-up, or had a non renal-related treatment failure were censored. Participants who completed the 104-week treatment period were censored at the Week 104 visit. Time to event is defined as event date minus treatment start date plus one. Analysis was performed using Cox proportional hazards model for the comparison between Belimumab and Placebo adjusting for induction regimen, race, Baseline uPCR and Baseline eGFR. Number of participants with time to death or renal related event up to Week 104 has been presented.
Secondary	Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104	Week 104	ORR is defined with respect to reproducible responses that included CRR, partial RR (PRR) and non responder. CRR is reported when uPCR was \<0.5, eGFR was not more than 10% below pre-flare GFR or within normal range and not a treatment failure. PRR is \>=50% decrease from Baseline in uPCR and one of the following: value \<1 if Baseline \<=3, or value \<3 if the Baseline was \>3, eGFR not more than 10% below Baseline GFR or within normal range and not a treatment failure and not a CRR. Non responder is reported when neither CRR nor PRR criteria was met. Percentage of participants reporting CRR, PRR and non responders at Week 104 has been presented.
Secondary	Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs	Up to Week 104	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs has been reported.
Secondary	Double-blind Period: Number of Participants Reporting AESI	Up to Week 104	An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths. On-treatment data is displayed.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	Week 104	mITT Population.	Percentage of participants	NUMBER
SECONDARY	Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	Week 104	mITT Population.	Percentage of participants	NUMBER
SECONDARY	Double-blind Period: Percentage of Participants With PERR at Week 52	Week 52	mITT Population.	Percentage of participants	NUMBER
SECONDARY	Double-blind Period: Number of Participants With Time to Death or Renal Related Event	Up to Week 104	mITT Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104	Week 104	mITT Population.	Percentage of participants	NUMBER
SECONDARY	Double-blind Period: Number of Participants Reporting On-treatment AEs and SAEs	Up to Week 104	Safety Population comprised of all randomized participants who received at least one dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Double-blind Period: Number of Participants Reporting AESI	Up to Week 104	Safety Population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-label Period: Number of Participants Reporting Adverse Events (AEs) and Serious AEs (SAEs)	From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)	Safety Open-Label Population comprised of all participants who received at least one dose of open-label treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Open-label Period: Number of Participants Reporting Adverse Events of Special Interest (AESI)	From first open-label dose (Day 1) up to open-label Week 32 (8 weeks after last dose)	Safety Open-Label Population.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group46

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

Outcome	Group	Category	Value	Units
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	Placebo		32.3	Percentage of participants
Double-blind Period: Percentage of Participants With Primary Efficacy Renal Response (PERR) at Week 104	Belimumab 10 mg/kg		43.0	Percentage of participants
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	Placebo		19.7	Percentage of participants
Double-blind Period: Percentage of Participants With Complete Renal Response (CRR) at Week 104	Belimumab 10 mg/kg		30.0	Percentage of participants
Double-blind Period: Percentage of Participants With PERR at Week 52	Placebo		35.4	Percentage of participants
Double-blind Period: Percentage of Participants With PERR at Week 52	Belimumab 10 mg/kg		46.6	Percentage of participants
Double-blind Period: Number of Participants With Time to Death or Renal Related Event	Placebo		63	Participants
Double-blind Period: Number of Participants With Time to Death or Renal Related Event	Belimumab 10 mg/kg		35	Participants
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104	Placebo	CRR	19.7	Percentage of participants
Double-blind Period: Percentage of Participants With Ordinal Renal Response (ORR) at Week 104	Belimumab 10 mg/kg	CRR	30.0	Percentage of participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Double-blind Period (Up to Week 104)	STARTED	Placebo to Belimumab 10 mg/kg	224
Double-blind Period (Up to Week 104)	STARTED	Belimumab 10 mg/kg to Belimumab 10	224
Double-blind Period (Up to Week 104)	COMPLETED	Placebo to Belimumab 10 mg/kg	170
Double-blind Period (Up to Week 104)	COMPLETED	Belimumab 10 mg/kg to Belimumab 10	186
Double-blind Period (Up to Week 104)	NOT COMPLETED	Placebo to Belimumab 10 mg/kg	54
Double-blind Period (Up to Week 104)	NOT COMPLETED	Belimumab 10 mg/kg to Belimumab 10	38
Open-label Period (Up to Week 28)	STARTED	Placebo to Belimumab 10 mg/kg	123
Open-label Period (Up to Week 28)	STARTED	Belimumab 10 mg/kg to Belimumab 10	132
Open-label Period (Up to Week 28)	COMPLETED	Placebo to Belimumab 10 mg/kg	122
Open-label Period (Up to Week 28)	COMPLETED	Belimumab 10 mg/kg to Belimumab 10	124

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events864

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	Upper respiratory tract infection	Infections and infestations	Placebo	74	224	134
other	Upper respiratory tract infection	Infections and infestations	Belimumab 10 mg/kg	81	224	159
other	Upper respiratory tract infection	Infections and infestations	Placebo to Belimumab 10 mg/kg	14	123	18
other	Upper respiratory tract infection	Infections and infestations	Belimumab 10 mg/kg to Belimumab 10 mg/kg	23	132	24
other	Urinary tract infection	Infections and infestations	Placebo	37	224	72
other	Urinary tract infection	Infections and infestations	Belimumab 10 mg/kg	43	224	73
other	Urinary tract infection	Infections and infestations	Placebo to Belimumab 10 mg/kg	10	123	12
other	Urinary tract infection	Infections and infestations	Belimumab 10 mg/kg to Belimumab 10 mg/kg	12	132	14
other	Nasopharyngitis	Infections and infestations	Placebo	31	224	50
other	Nasopharyngitis	Infections and infestations	Belimumab 10 mg/kg	35	224	60

1 to 10 of 864Source ClinicalTrials.gov

See all 864 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	5	224
Total, all-cause mortality	Belimumab 10 mg/kg	6	224
Total, all-cause mortality	Placebo to Belimumab 10 mg/kg	1	123
Total, all-cause mortality	Belimumab 10 mg/kg to Belimumab 10 mg/kg	0	132
Total, other adverse events	Placebo	191	224
Total, other adverse events	Belimumab 10 mg/kg	186	224
Total, other adverse events	Placebo to Belimumab 10 mg/kg	34	123
Total, other adverse events	Belimumab 10 mg/kg to Belimumab 10 mg/kg	39	132
Total, serious adverse events	Placebo	78	224
Total, serious adverse events	Belimumab 10 mg/kg	65	224

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32937045	DERIVED	PubMed
34560137	DERIVED	PubMed
36058429	DERIVED	PubMed
36302567	DERIVED	PubMed
37017254	DERIVED	PubMed
37463054	DERIVED	PubMed
42173278	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 comparisons1

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

Comparison
Belimumab 10 mg/kg vs Placebo: Double-blind Period: Number of Participants With Time to Death or Renal Related Event

Source 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.

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API reference For AI assistants