Lupus Membranous Nephropathy Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)
| Verified date | May 2020 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | February 3, 2020 |
| Est. primary completion date | May 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Key Inclusion Criteria: - Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of LMN (International Society of Nephrology [ISN] and the Renal Pathology Society [RPS] 2003 classification of lupus nephritis), either Class V alone, or Class V in combination with Class II. - Urine protein excretion = 1.5 grams per day - Estimated glomerular filtration rate (eGFR) = 40 mg/min/1.73m^2 based on the modification of diet in renal disease (MDRD) formulation at screening - No evidence of active or latent tuberculosis (TB) as assessed during screening Key Exclusion Criteria: - Prior treatments as follows: - Previous treatment with a janus kinase (JAK) inhibitor within 3 months of Day 1 - Use of rituximab or other selective B lymphocyte depleting agents (including experimental agents) within 6 months of Day 1. Enrollment is permitted if the last dose was given > 6 months and CD19-positive B cells are detectable at Screening. - Use of any concomitant prohibited medications as described in the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Emory University School of Medicine | Atlanta | Georgia |
| United States | University of Alabama at Birmingham (UAB) | Birmingham | Alabama |
| United States | University of North Carolina at Chapel Hill / UNC School of Medicine | Chapel Hill | North Carolina |
| United States | University of Florida | Gainesville | Florida |
| United States | Georgia Nephrology Research Institute | Lawrenceville | Georgia |
| United States | Stanford University | Palo Alto | California |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline; Week 16 | |
| Secondary | 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. | Baseline; Week 16 | |
| Secondary | Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Baseline; Week 16 | ||
| Secondary | 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. | Baseline; Week 16 | |
| Secondary | 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]). | Week 16 | |
| Secondary | 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. | Week 16 |