Clinical trial NCT01407874 (phase 2, status: completed)
Conditions: gout, hyperuricemia, arthritis, joint disease, renal insufficiency
ICD codes: M10.9, M10.08, M10.00, M10.011, M10.012, M10.019, M10.021, E79.0, A01.04, A02.23, A39.83, A39.84, A54.42, B06.82, B26.85, N25.0, Q61.4, N23, N26.9, P96.0, Q60.0, Q60.1
Drugs: placebo, ulodesine (bcx4208) 5 mg, ulodesine (bcx4208) 10 mg
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, OC[C@H]1CN(CC2=CNC3=C2N=CNC3=O)C[C@@H]1O, OC[C@H]1CN(CC2=CNC3=C2N=CNC3=O)C[C@@H]1O
Eligibility 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