Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/14/2017 |
Start Date: | June 2014 |
End Date: | August 2016 |
A Phase 2 Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
This study will evaluate the efficacy, safety, and tolerability of selonsertib (formerly
GS-4997) in participants with diabetic kidney disease (DKD). Participants will be randomized
with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or
matching placebo.
GS-4997) in participants with diabetic kidney disease (DKD). Participants will be randomized
with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or
matching placebo.
Key Inclusion Criteria:
- Adult male or females with prior diagnosis of Diabetic Kidney Disease
- Type 2 diabetes mellitus diagnosis for at least 6 months
- eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
- Urine albumin to creatinine ratio (UACR) as follows:
- Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
- Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g
- Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g
- Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor
blockers (ARB) at a minimum dose deemed appropriate for the individual by the
investigator and be at a stable dose for the last three months o Individuals not on
ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or
ARB
Key Exclusion Criteria:
- Type 1 diabetes mellitus
- Non-diabetic kidney disease
- UACR > 5000 mg/g on any measurement during screening
- End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status
post renal transplantation) or anticipated to occur within the treatment period
- Anticipated progression to ESRD (need for dialysis or listing for renal
transplantation) within the study treatment period
- Unstable cardiovascular disease
- Immunosuppressive drugs
- Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
101
sites
Click here to add this to my saved trials

Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
Click here to add this to my saved trials

Click here to add this to my saved trials

4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000

University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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

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

Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
Click here to add this to my saved trials

Click here to add this to my saved trials

University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Click here to add this to my saved trials

Click here to add this to my saved trials

1969 W Ogden Ave
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 864-6000

John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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

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

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

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

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

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

Click here to add this to my saved trials

University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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

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

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

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

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

Click here to add this to my saved trials

San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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

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

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
