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

N

National Institute of Cardiology Ignacio Chavez

Status and phase

Unknown
Phase 2

Conditions

Contrast-induced Acute Kidney Injury
Contrast-induced Nephropathy

Treatments

Drug: Placebo
Drug: Febuxostat
Drug: Allopurinol

Study type

Interventional

Funder types

Other

Identifiers

NCT03767322
PT-18-081

Details and patient eligibility

About

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

Full 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

Enrollment

558 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

558 participants in 3 patient groups, including a placebo group

Allopurinol group
Active Comparator group
Description:
The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
Treatment:
Drug: Allopurinol
Placebo group
Placebo Comparator group
Description:
The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
Treatment:
Drug: Placebo
Febuxostat group
Active Comparator group
Description:
The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
Treatment:
Drug: Febuxostat

Trial contacts and locations

1

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Central trial contact

Salvador Lopez-Gil, MD; Magdalena Madero, MD

Data sourced from clinicaltrials.gov

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