NCT05264584

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease stage3
• Contrast-induced Nephropathy

Interventions

Type	Name	Description
DRUG	Isotonic 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.
DRUG	N-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 .
DRUG	Febuxostat 80 MG	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-09-01
• Completion: 2022-02-01
• First posted: 2022-03-03
• Last updated: 2022-03-25

Locations

1 site across 1 country: Egypt