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
  Purpose

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


Condition Intervention Phase
Gout
Hyperuricemia
Arthritis
Joint Disease
Renal Insufficiency
Drug: Placebo
Drug: Ulodesine (BCX4208) 5 mg
Drug: Ulodesine (BCX4208) 10 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Placebo + Allopurinol 200mg
Drug: Placebo
Oral dose administered daily for 84 days.
Experimental: Ulodesine (BCX4208) 5mg
BCX4208 5mg + Allopurinol 200 mg
Drug: Ulodesine (BCX4208) 5 mg
Oral dose administered daily for 84 days.
Experimental: Ulodesine (BCX4208) 10mg
BCX4208 10mg + Allopurinol 200mg
Drug: Ulodesine (BCX4208) 10 mg
Oral dose administered daily for 84 days.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407874

Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Peoria, Arizona, United States, 85381
United States, California
Irvine, California, United States, 92618
United States, Florida
Oldsmar, Florida, United States, 34677
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Kansas
Newton, Kansas, United States, 67114
United States, Tennessee
Knoxville, Tennessee, United States, 37923
United States, Texas
Dallas, Texas, United States, 75235
San Antonio, Texas, United States, 78215
United States, Virginia
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Study Director: Alan Hollister, MD, PhD BioCryst Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01407874     History of Changes
Other Study ID Numbers: BCX4208-204
Study First Received: August 1, 2011
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BioCryst Pharmaceuticals:
Gout
Hyperuricemia
Arthritis
Joint Disease
Allopurinol
Renal Insufficiency

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Renal Insufficiency
Hyperuricemia
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
Allopurinol
Uric Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014