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Trial record 6 of 7206 for:    "Kidney Diseases"

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

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ClinicalTrials.gov Identifier: NCT02177786
Recruitment Status : Completed
First Posted : June 30, 2014
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

U.S. FDA Resources

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 estimated glomerular filtration rate (eGFR) from baseline at Week 48 [ Time Frame: Up to 48 weeks ]

Secondary Outcome Measures :
  1. Proportion of participants achieving at least a 30% reduction from baseline in albuminuria at Week 48 [ Time Frame: Up to 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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 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.


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


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Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02177786     History of Changes
Other Study ID Numbers: GS-US-223-1015
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Gilead Sciences:
Diabetic Kidney Disease
Gilead

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases