Phase 4
Completed N=940
CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
Gout · Chronic Kidney Diseases
Source: ClinicalTrials.gov NCT02579096 ↗
Enrolled (actual)
940
Serious AEs
26.4%
Results posted
Jan 2022
Primary outcomePrimary: Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 — 135; 165 Participants — p=<0.001
◆ Published Evidence
Highly cited
▲ Trending
102citations · ~26 / year
Comparative Effectiveness of Allopurinol and Febuxostat in Gout Management.
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.
Linked Publications (5)
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Comparative Effectiveness of Allopurinol and Febuxostat in Gout Management.
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Design and Rationale for the Veterans Affairs "Cooperative Study Program 594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat" Trial.
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Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement and inflammation modulators.
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Sustained xanthine oxidase inhibitor treat to target urate lowering therapy rewires a tight inflammation serum protein interactome.
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Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement activation and inflammation modulators.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 |
135; 165 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT02579096) and the linked publication. 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. Informational only — not medical advice.