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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gout, Moderate Renal Impairment

In brief

The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.

Key facts

Study ID

NCT02128490

Run by

Takeda

People needed

189

Starts

2014-05-01

Expected to finish

2015-10-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <60 mL/min at Screening visit (Day -21 for participants on urate lowering therapy (ULT) and Day -4 for participants not on ULT) or at the retest visit.
• Has at least one gout flare within 12 months prior to Screening visit.

You may not qualify if…

• Has received any investigational compound within 30 days prior to Screening.
• Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Is breastfeeding or pregnant.
• Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
• Has a history of xanthinuria.
• Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day 1/Randomization Visit.
• Has a known hypersensitivity to febuxostat or any components of their formulation; has a known hypersensitivity to naproxen, any other nonsteroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine or any components in their formulation.
• Has active peptic ulcer disease.
• Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the Screening Visit.
• Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values >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.

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Benny Green MD PA Family Practice — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bellflower, California, United States
• Study site — Escondido, California, United States
• Study site — Harbor City, California, United States
• Study site — Huntington Park, California, United States
• Study site — Irvine, California, United States
• Study site — Lomita, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Brigid Freyne MD — Murrieta, California, United States
• Study site — Murrieta, California, United States
• Study site — Orange, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Redondo Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Jose, California, United States
• Study site — San Ramon, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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