Conditions: Hyperuricosuria Kidney Stones
Keywords: Kidney Calculi Kidney Stones Nephrolithiasis Drug Therapy Uric Acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.

Detailed description:
Nephrolithiasis, also called kidney stone disease, occurs in patients with genetic susceptibility and who may have a broad spectrum of metabolic disorders and other comorbid conditions (for example obesity or diabetes). These renal stones develop as a result of supersaturation. Calcium oxalate (CaOx) is the most common type of stone. Reducing the urinary excretion of uric acid is an established approach for the treatment of CaOx kidney stones.

The objective of this study is to evaluate treatment with febuxostat compared to allopurinol or placebo in the reduction of 24-hour urine uric acid (uUA) excretion levels in hyperuricosuric patients with a recent history of renal stones and the presence of at least one CaOx stone larger than or equal to 3 mm as seen on Multidetector Computed Tomographic Angiography (MDCT).

Participants in this study will be required to make 4 office visits provide 3 urine samples and undergo 2 MDCT scans (a type of x-ray) of their kidneys.

Arms:
arm 1: Febuxostat 80 mg, capsules, orally, once daily for up to 6 months. arm 2: Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months. arm 3: Placebo-matching capsules, orally, once daily for up to 6 months.

Interventions: intervention 1: Febuxostat intervention 2: Allopurinol intervention 3: Placebo
Intervention descriptions: intervention 1: Febuxostat capsules intervention 2: Allopurinol capsules intervention 3: Placebo-matching capsules

Protocol document: