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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02177786
Recruitment Status : Completed
First Posted : June 30, 2014
Results First Posted : June 11, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Selonsertib Drug: Placebo to match selonsertib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selonsertib 2 mg
Participants will receive selonsertib 2 mg for 48 weeks.
Drug: Selonsertib
Tablets administered orally once daily
Other Name: GS-4997

Experimental: Selonsertib 6 mg
Participants will receive selonsertib 6 mg for 48 weeks.
Drug: Selonsertib
Tablets administered orally once daily
Other Name: GS-4997

Experimental: Selonsertib 18 mg
Participants will receive selonsertib 18 mg for 48 weeks.
Drug: Selonsertib
Tablets administered orally once daily
Other Name: GS-4997

Placebo Comparator: Placebo to match selonsertib
Participants will receive placebo to match selonsertib for 48 weeks.
Drug: Placebo to match selonsertib
Tablets administered orally once daily




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177786


Locations
Show Show 105 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02177786    
Other Study ID Numbers: GS-US-223-1015
First Posted: June 30, 2014    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: November 5, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Diabetic Kidney Disease
Gilead
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases