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Completed

NCT Number: NCT01082640

Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment

The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

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Key information

Conditions

Renal Impairment Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gout Hyperuricemia Joint Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Renal Insufficiency Rheumatic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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About this study

Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form in the body and settle in joints and other organs.

Approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. Hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function.

This study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment.

All participants must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All participants must meet the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). Participants are expected to return to the site for approximately 10 visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a serum urate greater than 7 mg/dL and a serum creatinine greater than or equal to 1.5 mg at Day -21
  • Must have a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout (the criteria related to tophi have been excluded for the purpose of the study)
  • Must have an estimated Glomerular Filtration Rate (eGFR) of 15 or greater, or less than or equal to 50 mL/min, AND a serum creatinine greater than 1.5 mg/dL at Screening Visit Day -21

Exclusion criteria

  • Has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant)
  • Has tophaceous gout
  • Has a history of xanthinuria
  • Has received aspirin greater than 325 mg/day within 35 days prior to Day 1/Randomization Visit
  • Has known hypersensitivity or allergy to allopurinol or any component in its formulation
  • Has known hypersensitivity to febuxostat or colchicine or any components in their formulation
  • Has myocardial infarction or stroke within the 90 days prior to the Screening Visit
  • Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal
  • Has end stage renal disease or is likely to be a candidate for dialysis over the 1 year study period
  • Has a serum creatinine less than or equal to 1.5 mg/dL, or an estimated Glomerular Filtration Rate at Day -21 Screening Visit less than 15 mL/min or greater than 50 mL/min as calculated by the central laboratory
  • Is required to take excluded medications

Treatment and study plan

Febuxostat

Drug

Febuxostat capsules

Other names: Uloric, TMX-67

Placebo

Drug

Febuxostat placebo-matching capsules

Primary outcomes

  1. Change From Baseline to Month 12 in Serum Creatinine

    Time frame: Baseline and Month 12

    Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.

Secondary outcomes

  1. Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline and Month 12

    Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).

  2. Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12

    Time frame: Month 12

    Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.

  3. Mean Clearance (CL/F) of Febuxostat at Steady State

    Time frame: The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.

    Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.

  4. Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State

    Time frame: The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.

    Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxostat Versus Placebo on Renal Function in Gout Subjects With Hyperuricemia and Moderate to Severe Renal Impairment

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2010
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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