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

NCT03767322 | Unknown Phase 2 DMC

• 1 other identifier: PT-18-081
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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)

Conditions

Contrast-induced Nephropathy; Contrast-induced Acute Kidney Injury

Keywords

contrast induced acute kidney injury; contrast induced nephropathy; allopurinol; febuxostat

Outcome Measures

Primary Outcomes (1)

• Prevention of contrast induced acute kidney injury

  Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours

  48 hours

Secondary Outcomes (2)

• Renal replacement therapy requirement

  7 days

• Length of hospitalization

  3 days to 90 days

Study Arms (3)

Allopurinol group

ACTIVE COMPARATOR

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

Drug: Allopurinol

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Febuxostat group

ACTIVE COMPARATOR

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

Drug: Febuxostat

Interventions

Allopurinol DRUG

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

Also known as: Zyloprim

Allopurinol group

Febuxostat DRUG

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

Also known as: Turazive

Febuxostat group

Placebo DRUG

Eligible patients will receive before and after coronary intervention

Placebo group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead
• Salvador López Gil: collaborator
• Armando Vázquez Rangel: collaborator

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, México City, Mexico

Location

Related Publications (5)

• 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.

  PMID: 28608311 BACKGROUND

• 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.

  PMID: 25653965 BACKGROUND

• 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.

  PMID: 27006404 BACKGROUND

• 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.

  PMID: 24942770 BACKGROUND

• 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.

  PMID: 25913922 BACKGROUND

MeSH Terms

Interventions

Allopurinol; Febuxostat

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Magdalena Madero, MD

  Instituto Nacional de Cardiologia Ignacio Chavez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Madero, MD

CONTACT

01 52 55 5573 2911; madero.magdalena@gmail.com

Salvador Lopez-Gil, MD

CONTACT

01 52 55 5573 2911; salvadorlgil@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Department

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: December 6, 2018
• Study Start: December 5, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-10

Locations

ME (1)