A Phase 2 interventional study of Filgotinib and Lanraplenib in Lupus Membranous Nephropathy, sponsored by Gilead Sciences. Completed at 7 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
Among 35 studies in Glomerulonephritis, Membranous with a site in United States — 13 open to participants now, 16 under way, 5 of them phase 3. Glomerulonephritis, Membranous · United States.
Among the 35 studies in Glomerulonephritis, Membranous with a site in United States, this one is the 28th largest by enrollment of the 32 interventional ones that give a count, is the only one that started in 2017, is one of 11 in phase 2, and was the 17th registered.
146 studies on the registry are indexed under Glomerulonephritis, Membranous; 60 are open to participants now.
Browse Glomerulonephritis, Membranous studies →13 of the 35 studies in Glomerulonephritis, Membranous with a site in United States are open now. Recruiting first, the newest first:
National Human Genome Research Institute (NHGRI) · Sites in United States
Ages 18–115
Amgen · Sites in United States
Ages 18–79
Pediatric Nephrology Research Consortium · Sites in United States
Ages up to 18
AstraZeneca · Sites in United States, Belgium, China and 6 more countries
Ages 18–75
Vertex Pharmaceuticals Incorporated · Sites in United States, Australia, Brazil and 11 more countries
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 41 Glomerulonephritis, Membranous studies recruiting now, 14 (34%) set no upper age limit and 14 (34%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 18 · Phase 3 7 · Phase 4 4
First in 2002; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 46 across 105 interventional studies indexed under Glomerulonephritis, Membranous.
Median enrollment 31 across the 32 interventional studies, 1,000 across the 3 observational. Of the 17 that completed or were terminated, 9 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 35 have an industry lead sponsor. The 10 most frequent:
Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
Gilead Sciences has 1 study filed under Glomerulonephritis, Membranous — fewer than ten, so there is no comparison to draw.
3 of the studies in Glomerulonephritis, Membranous with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707377Phase 3BeOne MedicinesA Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy | 2027-10 |
| NCT07157787Alexion Pharmaceuticals, Inc.Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) | 2027-07-02 |
| NCT07096843Climb Bio, Inc.A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy | 2027-10 |
Add all 3 to your calendar (.ics) → With an account.
Among the 35 studies in Glomerulonephritis, Membranous with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
Key Inclusion Criteria:
Key Exclusion Criteria:
Prior treatments as follows:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment. After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
Drug: Lanraplenib · Drug: Filgotinib placebo
Participants receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment. After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
Drug: Filgotinib · Drug: Lanraplenib placebo
At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive filgotinib 200 mg + lanraplenib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
Drug: Filgotinib · Drug: Lanraplenib placebo
At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive lanraplenib 30 mg + filgotinib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
Drug: Lanraplenib · Drug: Filgotinib placebo
200 mg tablet administered orally once daily
Also known as: GS-6034, GLPG0634
30 mg tablet administered orally once daily
Also known as: GS-9876
Tablet administered orally once daily
Tablet administered orally once daily
Percent Change in Urine Protein From Baseline (Day 1) to Week 16
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Time frame: Baseline; Week 16
Change From Baseline (Day 1) in Urine Protein at Week 16
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Time frame: Baseline; Week 16
Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
Time frame: Baseline; Week 16
Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16
UPCR was assessed by urine protein excretion during a 24-hour urine collection.
Time frame: Baseline; Week 16
Percentage of Participants With Partial Remission at Week 16
Partial Remission was defined as urine protein excretion below \< 3 g/day and urine protein excretion decrease by ≥ 50% among participants with baseline (Day 1) nephrotic range proteinuria \[urine protein excretion ≥ 3 g/day\]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria \[urine protein excretion \< 3 g/day\]).
Time frame: Week 16
Percentage of Participants With Complete Remission at Week 16
Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
Time frame: Week 16
Participants were enrolled at study sites in United States. The first participant was screened on 06 October 2017. The last study visit occurred on 03 February 2020.
| Milestone | Lanraplenib 30 mg | Filgotinib 200 mg | Lanraplenib 30 mg to Filgotinib 200 mg | Filgotinib 200 mg to Lanraplenib 30 mg |
|---|---|---|---|---|
| Started | 4 | 5 | 0 | 0 |
| Completed | 1 | 4 | 0 | 0 |
| Not completed | 3 | 1 | 0 | 0 |
| Withdrew: Adverse event | 2 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Milestone | Lanraplenib 30 mg | Filgotinib 200 mg | Lanraplenib 30 mg to Filgotinib 200 mg | Filgotinib 200 mg to Lanraplenib 30 mg |
|---|---|---|---|---|
| Started | 0 | 3 | 1 | 1 |
| Completed | 0 | 3 | 0 | 1 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 0 |
| Milestone | Lanraplenib 30 mg | Filgotinib 200 mg | Lanraplenib 30 mg to Filgotinib 200 mg | Filgotinib 200 mg to Lanraplenib 30 mg |
|---|---|---|---|---|
| Started | 0 | 3 | 0 | 1 |
| Completed | 0 | 2 | 0 | 1 |
| Not completed | 0 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 0 |
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
| percent change | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Percent Change in Urine Protein From Baseline (Day 1) to Week 16 | -2.8 | -51.2 ± 25.67 |
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
| g/day | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Change From Baseline (Day 1) in Urine Protein at Week 16 | -0.177 | -2.151 ± 2.2591 |
| mL/min/1.73 m^2 | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | -59.4 | -2.0 ± 11.35 |
UPCR was assessed by urine protein excretion during a 24-hour urine collection.
| mg/mg | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 | -4.407 | -0.808 ± 0.7539 |
Partial Remission was defined as urine protein excretion below \< 3 g/day and urine protein excretion decrease by ≥ 50% among participants with baseline (Day 1) nephrotic range proteinuria \[urine protein excretion ≥ 3 g/day\]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria \[urine protein excretion \< 3 g/day\]).
| percentage of participants | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Percentage of Participants With Partial Remission at Week 16 | 0 | 50.0 |
Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
| percentage of participants | Lanraplenib 30 mg | Filgotinib 200 mg |
|---|---|---|
| Percentage of Participants With Complete Remission at Week 16 | 0 | 0 |
Collected over First dose date up to the last dose date plus 30 days (maximum: 56 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Up to Week 16: Lanraplenib 30 mg | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Up to Week 16: Filgotinib 200 mg | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| After Week 16: Lanraplenib 30 mg | — | — | — |
| After Week 16: Filgotinib 200 mg | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Up to Week 16: Lanraplenib 30 mg | Up to Week 16: Filgotinib 200 mg | After Week 16: Lanraplenib 30 mg | After Week 16: Filgotinib 200 mg | After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg |
|---|---|---|---|---|---|---|
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 1/4 | 0/5 | — | 0/3 | 0/1 | 0/1 |
| Acute kidney injuryRenal and urinary disorders | 1/4 | 0/5 | — | 0/3 | 0/1 | 0/1 |
| Event | Up to Week 16: Lanraplenib 30 mg | Up to Week 16: Filgotinib 200 mg | After Week 16: Lanraplenib 30 mg | After Week 16: Filgotinib 200 mg | After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg |
|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/4 | 0/5 | — | 0/3 | 0/1 | 1/1 |
| NeutropeniaBlood and lymphatic system disorders | 0/4 | 2/5 | — | 0/3 | 0/1 | 1/1 |
| PainGeneral disorders | 0/4 | 0/5 | — | 0/3 | 0/1 | 1/1 |
| FuruncleInfections and infestations | 0/4 | 1/5 | — | 0/3 | 0/1 | 1/1 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/4 | 0/5 | — | 1/3 | 0/1 | 1/1 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/4 | 0/5 | — | 0/3 | 1/1 | 0/1 |
| RashSkin and subcutaneous tissue disorders | 0/4 | 0/5 | — | 0/3 | 0/1 | 1/1 |
| BronchitisInfections and infestations | 2/4 | 0/5 | — | 0/3 | 0/1 | 0/1 |
| Food poisoningGastrointestinal disorders | 0/4 | 0/5 | — | 1/3 | 0/1 | 0/1 |
| Oedema peripheralGeneral disorders | 1/4 | 0/5 | — | 1/3 | 0/1 | 0/1 |
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
| Age, Continuous(years) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Mean | 36 ± 15.8 | 35 ± 16.9 | 35 ± 15.4 |
| Sex: Female, Male(Participants) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 5 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| 24-Hour Urine Protein(g/day) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Mean | 6.0 ± 4.65 | 3.3 ± 2.47 | 4.5 ± 3.62 |
| Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m^2) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Mean | 116.1 ± 55.41 | 102.6 ± 30.61 | 108.6 ± 40.87 |
| Urine Protein Creatinine Ratio (UPCR)(mg/mg) | Lanraplenib 30 mg | Filgotinib 200 mg | Total |
|---|---|---|---|
| Mean | 5.1 ± 4.38 | 1.9 ± 1.04 | 3.3 ± 3.23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in May 2019, 18 months.
Results were first posted in May 2020, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: GLPG0634 · Lanraplenib
Glomerulonephritis, Membranous →