Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Selonsertib

Criteria

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

• 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

• HbA1c > 9.5%

• 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

• Unstable cardiovascular disease

• Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.