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

Investigator:  Michael E. Feldman, MD

Status: Recruiting

Phase: 2

Sponsor: Gilead Sciences

Contact: Lisa Baert, 541-706-6590 or lbaert@bmctotalcare.com

Location: Bend, Oregon (Central Oregon)

Purpose:  This study will evaluate the efficacy, safety, and tolerability of 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 GS-4997 (2 mg, 6 mg, or 18 mg) or matching placebo.

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

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

See this trial at ClinicalTrials.gov

For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.

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