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

Ain Shams University

Status: Completed

Conditions: Chronic Kidney Disease stage3; Contrast-induced Nephropathy

Treatments: Drug: Febuxostat 80 MG; Drug: N-acetyl cysteine; Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05264584

MS 616/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Volunteers: No 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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

control arm

Other group

Description:

This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).

Treatment:

Drug: Isotonic saline

Drug: N-acetyl cysteine

Febuxostat arm

Experimental group

Description:

This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .

Treatment:

Drug: Isotonic saline

Drug: N-acetyl cysteine

Drug: Febuxostat 80 MG