A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Re… (NCT03226899) | Clinical Trial Compass
TerminatedPhase 4
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
Stopped: This action was a business decision \& not related to any efficacy, safety or clinical concerns with lesinurad.
United States242 participantsStarted 2017-07-19
Plain-language summary
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is able to understand the study procedures, the risks involved, and willing to provide written informed consent before the first study related activity.
✓. Subject is willing to adhere to the protocol schedule.
✓. Subject is ≥ 18 years and ≤ 85 years of age.
✓. Subject has a diagnosis of gout.
✓. Subject has moderate renal impairment with estimated creatinine clearance (eCrCl; calculated by the Cockcroft-Gault formula using ideal body weight) 25.0 to ≤ 65.0 mL/min at Screening Visits 1 and 2 and an average eCrCl for both screening visits of 30.0 to \< 60.0 mL/min.
✓. Subject has been taking an XOI as ULT indicated for the treatment of gout for at least 4 weeks prior to Screening at a stable, medically appropriate dose, as determined by the Investigator. The minimum dose of allopurinol is 200 mg daily, and the minimum dose of febuxostat is the lowest approved dose per the local product label.
✓. Subject has a serum uric acid level ≥ 6.0 mg/dL (357 µmol/L) at Screening Visits 1 and 2.
✓. Subject is male or female; females must not be pregnant or breastfeeding and females of childbearing potential must agree to use nonhormonal contraception during the Screening Period and while taking investigation product (IP).
Exclusion criteria
✕. Subject had unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, or stroke within the last 6 months prior to randomization; or had a deep venous thrombosis within the previous 3 months prior to randomization.
What they're measuring
1
Percentage of Participants Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6
✕. Subject has uncontrolled hypertension (defined as systolic pressure above 160 or diastolic pressure above 95 mm Hg at either Screening Visits 1 or 2).
✕. Subject has severe hepatic impairment (defined as Child-Pugh Class C) or is known human immunodeficiency virus (HIV) positive.
✕. Subject is a solid organ transplant recipient.
✕. Subject has a urine protein of 3+ or higher by dipstick by the central laboratory at Screening Visit 2.
✕. Subject has a history of glomerulonephritis.
✕. Subject is taking valpromide, progabide, valproic acid, or other known inhibitors of epoxide hydrolase, or subject is taking ranolazine, cyclosporine, azathioprine or mercaptopurine.
✕. Subject is receiving chronic treatment with more than 325 mg of salicylates per day.