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

Contrast-induced Nephropathy Clinical Trial

— CI-AKI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03767322
• Other study ID #: PT-18-081
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 5, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Magdalena Madero, MD
• Phone: 01 52 55 5573 2911
• Email: madero.magdalena[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 558
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Acute Kidney Injury
• Contrast-induced Nephropathy
• Kidney Diseases
• Wounds and Injuries

Intervention

Drug:
• Allopurinol
Eligible patients will receive allopurinol 300 mg before and after coronary intervention
• Febuxostat
Eligible patients will receive febuxostat 80 mg before and after coronary intervention
• Placebo
Eligible patients will receive before and after coronary intervention

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico City	México City

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	Armando Vázquez Rangel, Salvador López Gil

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of contrast induced acute kidney injury	Increase in serum creatinine by = 0.3 mg/dl within 48 hours	48 hours
Secondary	Renal replacement therapy requirement	Initiation of renal replacement therapy	7 days
Secondary	Length of hospitalization	Length of hospitalization	3 days to 90 days