Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : December 5, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Turazive




Primary Outcome Measures :
  1. Prevention of contrast induced acute kidney injury [ Time Frame: 48 hours ]
    Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours


Secondary Outcome Measures :
  1. Renal replacement therapy requirement [ Time Frame: 7 days ]
    Initiation of renal replacement therapy

  2. Length of hospitalization [ Time Frame: 3 days to 90 days ]
    Length of hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767322


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez Not yet recruiting
Mexico City, México City, Mexico
Contact: Magdalena Madero, MD    015255 5573 2911 ext 21425    madero.magdalena@gmail.com   
Contact: Salvador Lopez-Gil, MD    015255 5573 2911 ext 21425    salvadorlgil@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Salvador López Gil
Armando Vázquez Rangel
Investigators
Layout table for investigator information
Principal Investigator: Magdalena Madero, MD Instituto Nacional de Cardiologia Ignacio Chavez

Publications:
Layout table for additonal information
Responsible Party: Magdalena Madero, Nephrology Department, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03767322     History of Changes
Other Study ID Numbers: PT-18-081
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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

Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
contrast induced acute kidney injury
contrast induced nephropathy
allopurinol
febuxostat

Additional relevant MeSH terms:
Layout table for MeSH terms
Febuxostat
Wounds and Injuries
Kidney Diseases
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs