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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01407874
First received: August 1, 2011
Last updated: October 28, 2013
Last verified: October 2013

August 1, 2011
October 28, 2013
September 2011
July 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
To evaluate the overall safety and tolerability of BCX4208 when combined with allopurinol in subjects with moderate renal insufficiency. [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]
Level of serum uric acid to be measured at Day 85.
Complete list of historical versions of study NCT01407874 on ClinicalTrials.gov Archive Site
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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
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

To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Gout
  • Hyperuricemia
  • Arthritis
  • Joint Disease
  • Renal Insufficiency
  • Drug: Placebo
    Oral dose administered daily for 84 days.
  • Drug: Ulodesine (BCX4208) 5 mg
    Oral dose administered daily for 84 days.
  • Drug: Ulodesine (BCX4208) 10 mg
    Oral dose administered daily for 84 days.
  • Experimental: Placebo
    Placebo + Allopurinol 200mg
    Intervention: Drug: Placebo
  • Experimental: Ulodesine (BCX4208) 5mg
    BCX4208 5mg + Allopurinol 200 mg
    Intervention: Drug: Ulodesine (BCX4208) 5 mg
  • Experimental: Ulodesine (BCX4208) 10mg
    BCX4208 10mg + Allopurinol 200mg
    Intervention: Drug: Ulodesine (BCX4208) 10 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥ 18 to < 70 years
  2. Have read and signed the Informed Consent Form
  3. Documented diagnosis of gout
  4. Documented moderate renal insufficiency
  5. Calculated creatinine clearance of ≥ 30 and < 60 mL/min
  6. Willing and able to take allopurinol 200 mg every day for the duration of the Treatment
  7. 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
  8. 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.
  9. 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)

Exclusion Criteria:

  1. Unable to tolerate allopurinol 200 mg every day
  2. Prior randomization in a clinical study with BCX4208
  3. 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
  4. Poorly controlled hypertension
  5. History of severe renal insufficiency
  6. Alanine aminotransferase or aspartate aminotransferase values > 2.0 x upper limit of normal
  7. CD4+ cell counts by flow cytometry < 500 cells/mm3
  8. Hemoglobin < 10 g/dL or > 18 g/dL (males) or < 10 g/dL or > 17 g/dL (females)
  9. White blood cell count < 3.7 x 109/L or > 11 x 109/L
  10. Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the next 4 months
  11. Positive serology for hepatitis B surface antigen or hepatitis C antibody or HIV type 1
  12. Immunocompromised due to illness or organ transplant
  13. Use of systemic immunosuppressive medications or disease-modifying antirheumatic drugs
  14. Use of azathioprine or 6-mercatopurine within 14 days of first dose of allopurinol
  15. Use of hydrochlorothiazide in doses > 50 mg per day
  16. Planned use of herbal or dietary supplements
  17. Recipient of any live or attenuated vaccine within 6 weeks of Screening
  18. Planned use of uric acid-lowering drugs other than allopurinol
  19. Use of systemic corticosteroids within 4 weeks prior to Day 1
  20. Use of any investigational drug within 30 days prior to signing the ICF
  21. History of clinically significant and relevant drug allergies
  22. History of chronic or recurrent infections
  23. History of any type of cancer not successfully treated or in full remission for 12 months prior to Screening
  24. History of alcohol or drug abuse within the year prior to the signing of the ICF, or current evidence of substance dependence or abuse
  25. Use of other prohibited medications within the timeframes specified in the protocol
  26. Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01407874
BCX4208-204
Yes
BioCryst Pharmaceuticals
BioCryst Pharmaceuticals
Not Provided
Study Director: Alan Hollister, MD, PhD BioCryst Pharmaceuticals
BioCryst Pharmaceuticals
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP