This is a phase 4 study to evaluate the safety and efficacy of Lesinurad 200mg in combination with a Xanthine Oxidase Inhibitor (XOI), compared with an XOI alone, in subjects with gout and moderate kidney disease who have not achieved target serum uric acid levels on an XOI alone. The study will last approximately 2 years and will involve up to 14 visits to the study site. You will be compensated for your time and travel to the study site up to $700.00 for completed study visits. Lesinurad was approved by the Food and Drug Administration ( FDA ) in December of 2015.
Gout is characterized by sudden, severe attacks of pain, redness and tenderness in joints, often the joint at the base of the big toe. Gout is a complex form of arthritis and can affect anyone. Men are more likely to get gout, but women become increasingly susceptible to gout after menopause. An attack of gout can occur suddenly, often waking you up in the middle of the night with the sensation that your big toe is on fire. The affected joint is hot, swollen and so tender that even the weight of the sheet on it may seem intolerable. The signs and symptoms of gout almost always occur suddenly, often at night and without warning. They include:
- Intense joint pain. Gout usually affects the large joint of your big toe, but it can occur in your feet, ankles, knees, hands and wrists. The pain is likely to be most severe within the first four to 12 hours after it begins.
- Lingering discomfort. After the most severe pain subsides, some joint discomfort may last from a few days to a few weeks. Later attacks are likely to last longer and affect more joints.
- Inflammation and redness. The affected joint or joints become swollen, tender, warm and red.
- Limited range of motion. Decreased joint mobility may occur as gout progresses.
Fortunately, gout is treatable, and there are ways to reduce the risk that gout will recur.