Skip to main content
OpenTrials
Completed

NCT Number: NCT02177786

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BC Diabetes, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selonsertib

Drug

Tablets administered orally once daily

Other names: GS-4997

Placebo to match selonsertib

Drug

Tablets administered orally once daily

Primary outcomes

  1. Change in eGFR From Baseline at Week 48

    Time frame: Baseline; Week 48

    The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).

Secondary outcomes

  1. Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48

    Time frame: Baseline; Week 48

    Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2014
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.