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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: Placebo to match selonsertib; Drug: Selonsertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177786

GS-US-223-1015

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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334 participants in 4 patient groups, including a placebo group

Selonsertib 2 mg

Experimental group

Description:

Participants will receive selonsertib 2 mg for 48 weeks.

Treatment:

Drug: Selonsertib

Selonsertib 6 mg

Experimental group

Description:

Participants will receive selonsertib 6 mg for 48 weeks.

Treatment:

Drug: Selonsertib

Selonsertib 18 mg

Experimental group

Description:

Participants will receive selonsertib 18 mg for 48 weeks.

Treatment:

Drug: Selonsertib

Placebo to match selonsertib

Placebo Comparator group

Description:

Participants will receive placebo to match selonsertib for 48 weeks.

Treatment:

Drug: Placebo to match selonsertib