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

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez (Other)

Overall Status

Unknown status

CT.gov ID

NCT03767322

Collaborator

Salvador López Gil (Other), Armando Vázquez Rangel (Other)

558

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Contrast-induced Nephropathy Contrast-induced Acute Kidney Injury	Drug: Allopurinol Drug: Febuxostat Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

558 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double blind clinical trial

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 5, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allopurinol group The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.	Drug: Allopurinol Eligible patients will receive allopurinol 300 mg before and after coronary intervention Other Names: Zyloprim
Placebo Comparator: Placebo group The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.	Drug: Placebo Eligible patients will receive before and after coronary intervention
Active Comparator: Febuxostat group The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention	Drug: Febuxostat Eligible patients will receive febuxostat 80 mg before and after coronary intervention Other Names: Turazive

Arm

Intervention/Treatment

Active Comparator: Allopurinol group

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

Drug: Allopurinol

Eligible patients will receive allopurinol 300 mg before and after coronary intervention

Other Names:

Zyloprim

Placebo Comparator: Placebo group

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

Drug: Placebo

Eligible patients will receive before and after coronary intervention

Active Comparator: Febuxostat group

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

Drug: Febuxostat

Eligible patients will receive febuxostat 80 mg before and after coronary intervention

Other Names:

Turazive

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Renal replacement therapy requirement [7 days]
Initiation of renal replacement therapy
Length of hospitalization [3 days to 90 days]
Length of hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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