Phase 4 N=940 Randomized Quadruple-blind Treatment

CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat

Gout · Chronic Kidney Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02579096 ↗

Enrolled (actual)

940

Serious AEs

26.4%

Results posted

Jan 2022

Primary outcome: Primary: Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 — 135; 165 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: allopurinol capsule, 100-800 mg by mouth once daily (Drug); febuxostat tablet 40-120 mg by mouth once daily (Drug); Placebo, vehicle control (febuxostat-shaped) (Drug); Placebo, vehicle control (allopurinol-shaped) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3	135; 165	<0.001 sig

Summary

This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time.

Eligibility Criteria

Inclusion Criteria

Age 18 years
History of gout - crystal proven or historical as defined by ACR criteria listed above
Serum urate level > 6.8 mg/dl

Exclusion Criteria

Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR 300 mg/day
Prior febuxostat use
Patients with malignancies that are currently active with exception of non-melanoma skin cancer
Patients with serum uric acid levels >15 mg/dl
Patients with myelodysplasia and hemoglobin of 1.7, not on Warfarin therapy
Bilirubin 2 mg/dL
Serum albumin < 3.5 mg/dL
Ascites
Encephalopathy
Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, probenecid, lesinurad or pegloticase
Enrollment in another randomized interventional clinical trial
Any severe medical condition that, in the enrolleer's opinion, is likely to compromise the participant's ability to complete the trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02579096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.