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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
200 mg tablet administered orally once daily
30 mg tablet administered orally once daily
Tablet administered orally once daily
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of Florida
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
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
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Tablet administered orally once daily
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, United States