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.
