Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

Inclusion Criteria

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
• Has a history or presence of gout defined as having one or more of the American Rheumatism Association (ARA) criteria for the diagnosis of gout:
• A tophus proven to contain urate crystals by chemical or polarized light microscopic means, AND/OR;
• Characteristic urate crystals in the joint fluid, AND/OR;
• History of at least 6 of the following clinical, laboratory, and x-ray phenomena:

i. more than one attack of acute arthritis, ii. maximum inflammation developed within 1 day, iii. monoarticular arthritis, iv. redness observed over joints, v. first metatarsophalangeal joint painful or swollen, vi. unilateral first metatarsophalangeal joint attack, vii. unilateral tarsal joint attack, viii. tophus (proven or suspected), ix. Hyperuricemia, x. asymmetric swelling within a joint on x-ray, xi. subcortical cysts without erosions on x-ray, xii. joint fluid culture negative for organisms during attack.

• Is male or female at least 18 years of age, inclusive.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
• Have a serum urate (sUA) level ≥8.0 mg/dL at the Day -4 Visit or at the retest visit.
• Has an estimated Glomerular Filtration Rate (eGRF) [Modification of Diet in Renal Disease (MDRD)] ≥30 mL/min and 2 x the upper limit of normal (ULN).
• Has rheumatoid arthritis which requires treatment.
• Has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
• Has experienced either a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA).
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening visit. Participant consumes >14 alcoholic beverages/week.
• Has participated in another investigational study within the 30 days prior to the Screening Visit.
• Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• Is required to take excluded medications.