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NCT05264584 Clinical Trial

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

Contrast-induced Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05264584
Other study ID # MS 616/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date February 1, 2022

Study information
Verified date February 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 .

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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 .
• 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.

Locations
Country Name City State
Egypt Ain shams university hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevention of CI-AKI incidence of CI-AKI after 48-72 hours after PCI 48-72 hours post contrast
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