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

NCT05264584 | Completed DMC

• 1 other identifier: MS 616/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease stage3; Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• prevention of CI-AKI

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

  48-72 hours post contrast

Study Arms (2)

control arm

OTHER

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

Drug: Isotonic saline; Drug: N-acetyl cysteine

Febuxostat arm

EXPERIMENTAL

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

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

Interventions

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.

Also known as: Saline

Febuxostat arm; control arm

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 .

Also known as: NAC

Febuxostat arm; control arm

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.

Also known as: Feburic 80

Febuxostat arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, 1181, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride; Acetylcysteine; Febuxostat

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rania Saad, Bachelor

  Faculty of medicine Ain shams university

  PRINCIPAL INVESTIGATOR

• Iman Sarhan, PhD

  Faculty of medicine Ain Shams university

  STUDY DIRECTOR

• Nahla Teama, PhD

  Faculty of medicine Ain Shams university

  STUDY CHAIR

• Yasser Alaa, PhD

  Faculty of medicine Ain Shams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 3, 2022
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)