Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05264584

Enrollment

120

Registered

2022-03-03

Start date

2020-12-01

Completion date

2022-02-01

Last updated

2022-03-25

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

Conditions

Chronic Kidney Disease stage3, Contrast-induced Nephropathy

Brief summary

This study will determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury in chronic kidney disease patients Stage 3 undergoing percutaneous coronary intervention.

Detailed description

In this randomised non blinded clinical trial, Investigators will study 120 CKD patients undergoing PCI to determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury . So, the patients will be divided into two arms based on block randomization. Each arm compromise 60 patients. The first arm will receive IV hydration and N-acetylcysteine (ctrl arm) . The second arm will receive IV hydration, N-acetylcysteine and Febuxostat (F arm). Block randomization will be used in this clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms.

Interventions

DRUGIsotonic saline

All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.

DRUGN-acetyl cysteine

all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .

DRUGFebuxostat 80 MG

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Age ≥ 18 years old . Patients under treatment of high dose statin(Atorvastatin (40-80 mg/day) . Glomerular filtration rate=30-59ml/min. Undergoing coronary PCI.

Exclusion criteria

Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .

Design outcomes

Primary

Measure	Time frame	Description
prevention of CI-AKI	48-72 hours post contrast	incidence of CI-AKI after 48-72 hours after PCI

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026