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Active Not Recruiting NCT07850713

Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With Hyperuricemia

Conditions: Hyperuricemia, Renal Insufficiency, Chronic

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: Nishtar Medical University

Location: Nishtar Hospital Multan Multan Punjab Province

Summary

This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Participants were to be assigned to receive either febuxostat 40 mg daily or allopurinol at a dose adjusted for their level of kidney function. Treatment was planned for eight weeks, with follow-up visits at weeks 4 and 8. The researchers hypothesized that the two medicines would differ in their effects after eight weeks. The main measure was the proportion of participants whose uric acid level reached below 6.0 mg/dL. Changes in uric acid levels and estimated kidney function were also to be compared.

Eligibility Criteria

Inclusion Criteria: * Adult patients of either gender between the ages of 18 and 65. * According to operational standards, chronic kidney disease was diagnosed in stages 3 to 5. * Hyperuricemia at baseline as per operational definition. * Clinically stable chronic kidney disease without acute deterioration within the preceding 4 weeks. * Not receiving febuxostat or allopurinol within the preceding 4 weeks, or suitable for protocol-defined washout if applicable. Exclusion Criteria: Exclusion criteria * Acute kidney injury or recent rapidly progressive decline in kidney function within the last 4 weeks. * Maintenance hemodialysis or peritoneal dialysis, or planned initiation of renal replacement therapy within the next 8 weeks. * History of kidney transplantation. * Known hypersensitivity or prior severe adverse reaction to allopurinol or febuxostat, including suspected allopurinol hypersensitivity syndrome. * Severe hepatic impairment or baseline alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal. * Active symptomatic gout flare at enrollment requiring immediate anti-inflammatory escalation that would confound urate assessment. * Use of other urate-lowering therapies within the last 4 weeks, such as probenecid, benzbromarone, pegloticase, rasburicase, or high-dose uricosurics. * Current chemotherapy, active malignancy with anticipated short-term clinical instability, or conditions associated with marked urate overproduction that require specialized management. * Uncontrolled heart failure or recent major cardiovascular event within the last 3 months, if local protocol mandates cardiovascular risk restriction for febuxostat initiation.

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Source: ClinicalTrials.gov (NCT07850713). StuddyBuddy aggregates publicly available trial information.