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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03767322

Acronym

CI-AKI

Enrollment

558

Registered

2018-12-06

Start date

2018-12-05

Completion date

2019-12-31

Last updated

2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-induced Acute Kidney Injury, Contrast-induced Nephropathy

Keywords

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

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

Interventions

DRUGAllopurinol

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

DRUGFebuxostat

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

DRUGPlacebo

Eligible patients will receive before and after coronary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blind clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Prevention of contrast induced acute kidney injury	48 hours	Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours

Secondary

Measure	Time frame	Description
Renal replacement therapy requirement	7 days	Initiation of renal replacement therapy
Length of hospitalization	3 days to 90 days	Length of hospitalization

Countries

Mexico

Contacts

Primary ContactMagdalena Madero, MD

madero.magdalena@gmail.com01 52 55 5573 2911

Backup ContactSalvador Lopez-Gil, MD

salvadorlgil@gmail.com01 52 55 5573 2911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026