A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
1 other identifier
interventional
20
1 country
10
Brief Summary
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2011
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 20, 2013
October 1, 2013
10 months
August 1, 2011
October 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency by assessment of percent change from baseline in CD4+ lymphocytes at Day 85.
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
85 days
Study Arms (3)
Placebo
EXPERIMENTALPlacebo + Allopurinol 200mg
Ulodesine (BCX4208) 5mg
EXPERIMENTALBCX4208 5mg + Allopurinol 200 mg
Ulodesine (BCX4208) 10mg
EXPERIMENTALBCX4208 10mg + Allopurinol 200mg
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 to \< 70 years
- Have read and signed the Informed Consent Form
- Documented diagnosis of gout
- Documented moderate renal insufficiency
- Calculated creatinine clearance of ≥ 30 and \< 60 mL/min
- Willing and able to take allopurinol 200 mg every day for the duration of the Treatment
- Female participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence for 4 weeks after completion of study drug, surgically sterile, postmenopausal,use oral contraceptives for three months prior to study drug dosing through 4 weeks after completion of study drug, an intrauterine device for 8 weeks prior to study drug dosing through 4 weeks after completion of study drug,double barrier contraception method for 4 weeks prior to study drug dosing through 4 weeks after completion of study drug administration
- Male participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence through 90 days after completion of study drug, be \> 1 year postvasectomy, agree to use a condom with spermicide from the start of study drug dosing through 90 days after completion of study drug.
- Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA)
You may not qualify if:
- Unable to tolerate allopurinol 200 mg every day
- Prior randomization in a clinical study with BCX4208
- Unstable cardiac disease such as: unstable angina, symptomatic arrhythmia, signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina, history of long QT syndrome, or QTc interval \< 350 msec or \> 475 msec
- Poorly controlled hypertension
- History of severe renal insufficiency
- Alanine aminotransferase or aspartate aminotransferase values \> 2.0 x upper limit of normal
- CD4+ cell counts by flow cytometry \< 500 cells/mm3
- Hemoglobin \< 10 g/dL or \> 18 g/dL (males) or \< 10 g/dL or \> 17 g/dL (females)
- White blood cell count \< 3.7 x 109/L or \> 11 x 109/L
- Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the next 4 months
- Positive serology for hepatitis B surface antigen or hepatitis C antibody or HIV type 1
- Immunocompromised due to illness or organ transplant
- Use of systemic immunosuppressive medications or disease-modifying antirheumatic drugs
- Use of azathioprine or 6-mercatopurine within 14 days of first dose of allopurinol
- Use of hydrochlorothiazide in doses \> 50 mg per day
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Irvine, California, 92618, United States
Unknown Facility
Oldsmar, Florida, 34677, United States
Unknown Facility
Honolulu, Hawaii, 96814, United States
Unknown Facility
Newton, Kansas, 67114, United States
Unknown Facility
Knoxville, Tennessee, 37923, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Alexandria, Virginia, 22304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alan Hollister, MD, PhD
BioCryst Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 2, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 20, 2013
Record last verified: 2013-10