Renoprotective Effect of Febuxostat on… | Clinical Trial

Key information

Conditions

Chronic Kidney Disease stage3 Contrast-induced Nephropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university hospitals

Cairo, 1181, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Isotonic saline

Drug

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.

Other names: Saline

N-acetyl cysteine

Drug

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 .

Other names: NAC

Febuxostat 80 mg

Drug

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.

Other names: Feburic 80

Primary outcomes

prevention of CI-AKI

Time frame: 48-72 hours post contrast

incidence of CI-AKI after 48-72 hours after PCI

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Mar 3, 2022
Registry last updated: Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed