Adults 18 to 75, any sex, with Glomerulonephritis, Membranous. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Proteinuria Levels at Week 28Primary· Baseline and Week 28
Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all e
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.7552
± 45.0
Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28Primary· Baseline and Week 28
PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.2666
± 171.0
Proteinuria Levels at the Indicated Time PointsSecondary· Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Baseline, n=14
Group
Value
95% CI
Belimumab 10 mg/kg IV
724.3157
± 40.2
Week 12, n=13
Group
Value
95% CI
Belimumab 10 mg/kg IV
670.8655
± 46.9
Week 28, n=11
Group
Value
95% CI
Belimumab 10 mg/kg IV
498.1255
± 40.9
Week 52, n=9
Group
Value
95% CI
Belimumab 10 mg/kg IV
356.4209
± 174.8
Week 76, n=8
Group
Value
95% CI
Belimumab 10 mg/kg IV
274.9714
± 70.4
Week 104, n=10
Group
Value
95% CI
Belimumab 10 mg/kg IV
129.9761
± 186.0
Week 128, n=9
Group
Value
95% CI
Belimumab 10 mg/kg IV
75.2359
± 136.4
Change From Baseline in Proteinuria Levels at the Indicated Time PointsSecondary· Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up
Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in th
Week 12; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.9437
± 39.3
Week 28; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.7552
± 45.0
Week 52; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.5297
± 206.7
Week 76; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.4177
± 54.3
Week 104; n= 10
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.1874
± 189.3
Week 128; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.1118
± 139.1
Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time PointsSecondary· Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Baseline, n=14
Group
Value
95% CI
Belimumab 10 mg/kg IV
168.3
± 138.9
Week 12, n=13
Group
Value
95% CI
Belimumab 10 mg/kg IV
91.0
± 200.4
Week 28, n=11
Group
Value
95% CI
Belimumab 10 mg/kg IV
46.4
± 319.6
Week 52, n=9
Group
Value
95% CI
Belimumab 10 mg/kg IV
12.9
± 358.4
Week 76, n=8
Group
Value
95% CI
Belimumab 10 mg/kg IV
7.5
± 140.4
Week 104, n=10
Group
Value
95% CI
Belimumab 10 mg/kg IV
3.7
± 72.7
Week 128, n=8
Group
Value
95% CI
Belimumab 10 mg/kg IV
4.4
± 112.0
Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time PointsSecondary· Baseline and Weeks 12, 28, 52, 76, 104 and 128.
Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Week 12; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.5362
± 58.1
Week 28; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.2666
± 171.0
Week 52; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.0737
± 130.3
Week 76; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.0436
± 102.8
Week 104; n= 10
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.0212
± 169.1
Week 128; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0.0284
± 243.7
Number of Participants With Complete or Partial RemissionSecondary· Baseline and Weeks 12, 28, 52, 76, 104 and 128
Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3grams \[g\]/24 h) with no worsening in renal function (estimated glomerular filtration rate \[eGFR\] reduction from Baseline \<15 percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Week 12; Partial remission; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 12; Complete remission; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 28; Partial remission; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
1
Week 28; Complete remission; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 52; Partial remission; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
2
Week 52; Complete remission; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
1
Week 76; Partial remission; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
3
Week 76; Complete remission; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Time to Complete or Partial RemissionSecondary· Baseline and up to Week 128/6 month follow up
Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15 percent ). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for comple
Group
Value
95% CI
Belimumab 10 mg/kg IV
68.20
28.00 – 93.60
Duration of Complete or Partial RemissionSecondary· Baseline and up to Week 128/6 month follow up
Complete remission is defined as PCR \<30 mg/mmol (proteinuria \<0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline \<15percent). Partial remission is defined as PCR \<350 mg/mmol (proteinuria \<3.5 g/24 h) but \>= 30 mg/mmol (proteinuria \>= 0.3g/24h) and decrease of \>50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline \<15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participa
Complete remission; n= 1
Group
Value
95% CI
Belimumab 10 mg/kg IV
365.0
± NA
Partial remission; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
378.6
± 186.15
Number of Participants With PLA2R Autoantibody RemissionSecondary· Baseline and Weeks 12, 28, 52, 76, 104 and 128
Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Week 12; full response; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
1
Week 12; partial response; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
3
Week 28; full response; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
3
Week 28; partial response; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
6
Week 52; full response; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
4
Week 52; partial response; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
5
Week 76; full response; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
4
Week 76; partial response; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
4
Time to Anti-PLA2R Autoantibody RemissionSecondary· Baseline and up to Week 128/6 month follow up
Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.
Partial response
Group
Value
95% CI
Belimumab 10 mg/kg IV
16.20
8.00 – 24.00
Complete response
Group
Value
95% CI
Belimumab 10 mg/kg IV
82.00
16.00 – 92.00
Number of Participants With Anti-PLA2R Autoantibody RelapseSecondary· Baseline and up to Week 128/6 month follow up
Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Week 12; n= 13
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 28; n= 11
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 52; n= 9
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 76; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 104; n= 10
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Week 128; n= 8
Group
Value
95% CI
Belimumab 10 mg/kg IV
0
Adverse events — posted to ClinicalTrials.gov
Time frame: On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to end of study..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R) autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive IMGN followed by a further long term treatment period until subjects reach remission of proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background supportive therapy throughout the study. The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000 milligrams per millimole (mg/mmol) \[greater than 10 grams(g)/24 hours (h)\], to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other measures of kidney function. These will be compared to historical data. The pharmacokinetics of belimumab will be measured to confirm dosing in heavily proteinuric subjects. Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also be investigated. Safety will be assessed by adverse events (AE), clinical laboratory evaluations, and vital signs.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 13 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01610492.