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

Primary Purpose

Contrast-induced Nephropathy, Contrast-induced Acute Kidney Injury

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Allopurinol
Febuxostat
Placebo
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring contrast induced acute kidney injury, contrast induced nephropathy, allopurinol, febuxostat

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Cardiologia Ignacio Chavez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Allopurinol group

Placebo group

Febuxostat group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Renal replacement therapy requirement
Initiation of renal replacement therapy
Length of hospitalization
Length of hospitalization

Full Information

First Posted
October 14, 2018
Last Updated
December 5, 2018
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
Salvador López Gil, Armando Vázquez Rangel
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1. Study Identification

Unique Protocol Identification Number
NCT03767322
Brief Title
Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
Acronym
CI-AKI
Official Title
Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2018 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
Salvador López Gil, Armando Vázquez Rangel

4. Oversight

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
Data Monitoring Committee
Yes

5. 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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy, Contrast-induced Acute Kidney Injury
Keywords
contrast induced acute kidney injury, contrast induced nephropathy, allopurinol, febuxostat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double blind clinical trial
Allocation
Randomized
Enrollment
558 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol group
Arm Type
Active Comparator
Arm Description
The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
Arm Title
Febuxostat group
Arm Type
Active Comparator
Arm Description
The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Zyloprim
Intervention Description
Eligible patients will receive allopurinol 300 mg before and after coronary intervention
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Turazive
Intervention Description
Eligible patients will receive febuxostat 80 mg before and after coronary intervention
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Eligible patients will receive before and after coronary intervention
Primary Outcome Measure Information:
Title
Prevention of contrast induced acute kidney injury
Description
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Renal replacement therapy requirement
Description
Initiation of renal replacement therapy
Time Frame
7 days
Title
Length of hospitalization
Description
Length of hospitalization
Time Frame
3 days to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Madero, MD
Phone
01 52 55 5573 2911
Ext
21425
Email
madero.magdalena@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador Lopez-Gil, MD
Phone
01 52 55 5573 2911
Ext
21425
Email
salvadorlgil@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Organizational Affiliation
Instituto Nacional de Cardiologia Ignacio Chavez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Mexico City
State/Province
México City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Phone
015255 5573 2911
Ext
21425
Email
madero.magdalena@gmail.com
First Name & Middle Initial & Last Name & Degree
Salvador Lopez-Gil, MD
Phone
015255 5573 2911
Ext
21425
Email
salvadorlgil@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28608311
Citation
Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
Results Reference
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PubMed Identifier
25653965
Citation
Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
Results Reference
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PubMed Identifier
27006404
Citation
Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
Results Reference
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PubMed Identifier
24942770
Citation
Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
Results Reference
background
PubMed Identifier
25913922
Citation
Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
Results Reference
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Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

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