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

Not Applicable

Completed

• Conditions: Contrast-induced Nephropathy; Chronic Kidney Disease stage3
• Interventions: Drug: Isotonic saline; Drug: N-acetyl cysteine; Drug: Febuxostat 80 MG

• Registration Number: NCT05264584
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-09-01
• Status Verified: 2022-02
• Study Completion: 2022-02-01
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat arm	Febuxostat 80 MG	This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .
control arm	Isotonic saline	This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).
control arm	N-acetyl cysteine	This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).
Febuxostat arm	Isotonic saline	This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .
Febuxostat arm	N-acetyl cysteine	This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .

Primary Outcome Measures

Name	Time	Method
prevention of CI-AKI	48-72 hours post contrast	incidence of CI-AKI after 48-72 hours after PCI

Trial Locations

Locations (1)

Ain shams university hospitals; 🇪🇬 Cairo, Egypt