Safety and Efficacy of Filgotinib and GS-9876 in Adults With Lupus Membranous Nephropathy (LMN)
Status: | Active, not recruiting |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/10/2019 |
Start Date: | October 6, 2017 |
End Date: | April 2021 |
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)
The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in
adults with Lupus Membranous Nephropathy (LMN).
adults with Lupus Membranous Nephropathy (LMN).
Key Inclusion Criteria:
- Male or female between 18 and 75 years of age, inclusive, at the time of initial
informed consent
- 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 (eGFRMDRD) ≥ 40 mg/min/1.73m^2 based on the MDRD
formulation at screening
- No evidence of active or latent TB as assessed during screening
Key Exclusion Criteria:
- Prior treatments as follows:
- Previous treatment with a 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.
We found this trial at
14
sites
Click here to add this to my saved trials

Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
Click here to add this to my saved trials

University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials

Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Click here to add this to my saved trials

University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials

Click here to add this to my saved trials

Chapel Hill, North Carolina 27707
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Temple University Temple University is many things to many people. A place to pursue life's...
Click here to add this to my saved trials

Click here to add this to my saved trials
