Effect of febuxostat on disease progression in patients of chronic kidney disease with high uric acid levels in the blood.

Efficacy and safety of febuxostat for retarding progression in chronic kidney disease with asymptomatic hyperuricemia: a double blind, randomized, placebo controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004853

Enrollment

Registered

2014-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: null- Patients with Chronic Kidney disease stage 3/4

Interventions

Intervention1: Febuxostat: Xanthine Oxidase inhibitor Intervention2: Febuxostat: Xanthine Oxidase Inhibitor packaged as tablets of strength of 40 mg each given per oral once daily for 6 months Control

Eligibility

Inclusion criteria

Inclusion criteria: (1) CKD stages 3 and 4 as determined by calculated creatinine clearances. (2) Serum uric acid level more than 6 mg/dl

Exclusion criteria

Exclusion criteria: 1.requirement of medication (excluding diuretics) or conditions which may increase uric acid levels, such as disorders of primary uric acid metabolism. 2.autosomal dominant polycystic kidney disease 3. Patients with pregnancy, lactation 4. Symptomatic hyperuricemia or gout were also excluded from the trial.

Design outcomes

Primary

Measure	Time frame
The proportion of patients showing a greater than 10% decline of eGFR from baseline in the study and control populations.Timepoint: 6 months	—

Secondary

Measure	Time frame
1. The change in estimated glomerular filtration rate in the two groups from the baseline and at the end of the study period.Timepoint: 6 months;cardiovascular events (myocardial infarction, strokes or heart failure),Timepoint: 6 months;death due to any causeTimepoint: 6 months;development of CKD-V stage (drop in eGFR below 15 ml/min)Timepoint: 6 months;Uric acid levels in the study and control populationTimepoint: 6 months;development of any drug related adverse eventsTimepoint: 6 months	—

Measure

Time frame

1. The change in estimated glomerular filtration rate in the two groups from the baseline and at the end of the study period.Timepoint: 6 months;cardiovascular events (myocardial infarction, strokes or heart failure),Timepoint: 6 months;death due to any causeTimepoint: 6 months;development of CKD-V stage (drop in eGFR below 15 ml/min)Timepoint: 6 months;Uric acid levels in the study and control populationTimepoint: 6 months;development of any drug related adverse eventsTimepoint: 6 months

—

Countries

India

Contacts

Public ContactSoumya Chatterjee

Institute of Postgraduate Medical Education and Research, Kolkata

lahiri.arpi@gmail.com9433407355

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026