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

National Institute of Cardiology Ignacio Chavez

Status and phase: Unknown; Phase 2

Conditions: Contrast-induced Acute Kidney Injury; Contrast-induced Nephropathy

Treatments: Drug: Febuxostat; Drug: Allopurinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03767322

PT-18-081

Details and patient eligibility

About

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

Full 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

Enrollment: 558 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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558 participants in 3 patient groups, including a placebo group

Allopurinol group

Active Comparator group

Description:

The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.

Treatment:

Drug: Allopurinol

Placebo group

Placebo Comparator group

Description:

The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.

Treatment:

Drug: Placebo

Febuxostat group

Active Comparator group

Description:

The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention

Treatment:

Drug: Febuxostat