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

December 5, 2018 updated by: Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

558

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • México City
      • Mexico City, México City, Mexico
        • Instituto Nacional de Cardiologia Ignacio Chavez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of contrast induced acute kidney injury
Time Frame: 48 hours
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal replacement therapy requirement
Time Frame: 7 days
Initiation of renal replacement therapy
7 days
Length of hospitalization
Time Frame: 3 days to 90 days
Length of hospitalization
3 days to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Collaborators

Salvador López Gil
Armando Vázquez Rangel

Investigators

  • Principal Investigator: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 5, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-18-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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