Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
A Multicenter, Randomized, Double-Blind, Placebo and Allopurinol Controlled, Phase 2 Study to Evaluate Febuxostat in the Medical Management of Subjects With Hyperuricosuria and Calcium Oxalate Stones
2 other identifiers
interventional
99
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2010
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
February 15, 2013
CompletedFebruary 15, 2013
January 1, 2013
1.7 years
February 25, 2010
October 15, 2012
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion
The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.
Baseline and Month 6
Secondary Outcomes (3)
Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone
Baseline and Month 6
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones
Baseline and Month 6
Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance
Baseline and Month 6
Study Arms (3)
Febuxostat
EXPERIMENTALFebuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Allopurinol
ACTIVE COMPARATORAllopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
Placebo
PLACEBO COMPARATORPlacebo-matching capsules, orally, once daily for up to 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Has hyperuricosuria, defined as a daily urine uric acid excretion greater than 700 mg as measured by 24-hour urine collection prior to randomization.
- Has at least one calcium oxalate stone greater than or equal to 3 mm in its longest in-plane diameter, identified by Multiple Detector Computated Tomography prior to randomization.
- Has a recent (within the previous 5 years) history of renal stones prior to screening.
You may not qualify if:
- Has gout, secondary hyperuricemia or has experienced a gout flare.
- Has a history of xanthinuria.
- Has received allopurinol or probenecid within 2 years prior to randomization.
- Has received febuxostat.
- Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal at the Screening Visit.
- Has an abnormal serum calcium level at the Screening Visit.
- Has a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol according to the judgment of the Investigator.
- Has a history of drug abuse or a history of alcohol abuse within 5 years prior to the Screening Visit.
- Participant's measured creatinine clearance is less than 30 mL/min at the Screening Visit.
- Has hypercalciuria at Screening, while on a regular unrestricted diet, defined as urinary excretion of:
- greater than 250 mg of calcium/24-hour for females of body weight less than 62.5 kg; OR
- greater than 300 mg calcium/24-hour for males of body weight less than 75 kg; OR
- greater than 4 mg calcium/kg/24-hour for males of body weight greater than or equal 75 kg and females of body weight greater than or equal 62.5 kg.
- EXCLUDED MEDICATIONS:
- Febuxostat, allopurinol, probenecid.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (28)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Anchorage, Alaska, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Palmdale, California, United States
Unknown Facility
Poway, California, United States
Unknown Facility
Rancho Cucamonga, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
New Britain, Connecticut, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New Windsor, New York, United States
Unknown Facility
Shelby, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
East Providence, Rhode Island, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Sugar Land, Texas, United States
Related Publications (1)
Goldfarb DS, MacDonald PA, Gunawardhana L, Chefo S, McLean L. Randomized controlled trial of febuxostat versus allopurinol or placebo in individuals with higher urinary uric acid excretion and calcium stones. Clin J Am Soc Nephrol. 2013 Nov;8(11):1960-7. doi: 10.2215/CJN.01760213. Epub 2013 Aug 8.
PMID: 23929928DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Senior Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
March 1, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 15, 2013
Results First Posted
February 15, 2013
Record last verified: 2013-01