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

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ClinicalTrials.gov Identifier: NCT03767322
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Salvador López Gil
Armando Vázquez Rangel
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

Tracking Information
First Submitted Date  ICMJE October 14, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Estimated Study Start Date  ICMJE December 5, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Prevention of contrast induced acute kidney injury [ Time Frame: 48 hours ]
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Renal replacement therapy requirement [ Time Frame: 7 days ]
    Initiation of renal replacement therapy
  • Length of hospitalization [ Time Frame: 3 days to 90 days ]
    Length of hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
Official Title  ICMJE Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blind clinical trial
Primary Purpose: Prevention
Condition  ICMJE
  • Contrast-induced Nephropathy
  • Contrast-induced Acute Kidney Injury
Intervention  ICMJE
  • Drug: Allopurinol
    Eligible patients will receive allopurinol 300 mg before and after coronary intervention
    Other Name: Zyloprim
  • Drug: Febuxostat
    Eligible patients will receive febuxostat 80 mg before and after coronary intervention
    Other Name: Turazive
  • Drug: Placebo
    Eligible patients will receive before and after coronary intervention
Study Arms  ICMJE
  • Active Comparator: Allopurinol group
    The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Placebo group
    The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
    Intervention: Drug: Placebo
  • Active Comparator: Febuxostat group
    The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
    Intervention: Drug: Febuxostat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
558
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Magdalena Madero, MD 01 52 55 5573 2911 ext 21425 madero.magdalena@gmail.com
Contact: Salvador Lopez-Gil, MD 01 52 55 5573 2911 ext 21425 salvadorlgil@gmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767322
Other Study ID Numbers  ICMJE PT-18-081
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
Study Sponsor  ICMJE Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators  ICMJE
  • Salvador López Gil
  • Armando Vázquez Rangel
Investigators  ICMJE
Principal Investigator: Magdalena Madero, MD Instituto Nacional de Cardiologia Ignacio Chavez
PRS Account Instituto Nacional de Cardiologia Ignacio Chavez
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP