Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

Phase 2

• Conditions: Contrast-induced Nephropathy; Contrast-induced Acute Kidney Injury
• Interventions: Drug: Placebo; Drug: Allopurinol; Drug: Febuxostat

• Registration Number: NCT03767322
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)

Detailed Description

Eligible patients (patients with glomerular filtration rate \< 60 ml/min or high riks patients based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1 exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post radiocontrast exposure) or placebo and hydration.

Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-14
• Study Start: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

• Age 18 years and older who are scheduled to coronary intervention
• Patients with Mehran score > 5 or modified Mehran score >2 even glomerular filtration rate > 60 ml/min (high risk patients)
• Glomerular Filtration Rate < 60 ml/min
• All the patients provided written informed consent for the procedures and the test drug

Exclusion Criteria

• Patients with shorter hospital stay (<48 hours)
• Patients under treatment with allopurinol of febuxostat
• Patients on renal replacement therapy
• Known allergy to allopurinol or febuxostat

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
Allopurinol group	Allopurinol	The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
Febuxostat group	Febuxostat	The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention

Primary Outcome Measures

Name	Time	Method
Prevention of contrast induced acute kidney injury	48 hours	Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours

Secondary Outcome Measures

Name	Time	Method
Renal replacement therapy requirement	7 days	Initiation of renal replacement therapy
Length of hospitalization	3 days to 90 days	Length of hospitalization

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia Ignacio Chavez; 🇲🇽 Mexico City, México City, Mexico