Clinical Trials Logo
  1. Home
  2. Contrast-induced Nephropathy
  3. NCT05264584
  4. Details
NCT05264584 Clinical Trial

Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Contrast-induced Nephropathy Clinical Trial

Official title:
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05264584
Other study ID # MS 616/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date February 1, 2022

Study information
Verified date February 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury in chronic kidney disease patients Stage 3 undergoing percutaneous coronary intervention.

Description:

In this randomised non blinded clinical trial, Investigators will study 120 CKD patients undergoing PCI to determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury . So, the patients will be divided into two arms based on block randomization. Each arm compromise 60 patients. The first arm will receive IV hydration and N-acetylcysteine (ctrl arm) . The second arm will receive IV hydration, N-acetylcysteine and Febuxostat (F arm). Block randomization will be used in this clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Age = 18 years old . Patients under treatment of high dose statin(Atorvastatin (40-80 mg/day) . Glomerular filtration rate=30-59ml/min. Undergoing coronary PCI. Exclusion Criteria: Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Isotonic saline
All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.
• N-acetyl cysteine
all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .
• Febuxostat 80 MG
All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.

Locations
Country Name City State
Egypt Ain shams university hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevention of CI-AKI incidence of CI-AKI after 48-72 hours after PCI 48-72 hours post contrast
See also
  Status Clinical Trial Phase
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT02088502 - Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy Phase 2/Phase 3
Completed NCT03329443 - The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography Phase 2
Recruiting NCT04864847 - Clinical Validation of the RENISCHEM L-FABP POC Assay
Completed NCT03627130 - The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy Phase 2
Active, not recruiting NCT03736018 - Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients N/A
Withdrawn NCT04603261 - Time to Excretion of Contrast, a Maastricht Prospective Observational Study
Withdrawn NCT04598516 - Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30
Recruiting NCT03755700 - Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization Phase 3
Active, not recruiting NCT04606056 - Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans
Terminated NCT02440646 - Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging
Completed NCT00175227 - Prevention of Contrast-Induced Nephropathy N/A
Completed NCT04014153 - CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
Withdrawn NCT04597892 - Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast
Completed NCT03305874 - Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization
Not yet recruiting NCT01871792 - Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction Phase 4
Not yet recruiting NCT06429345 - Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients. Phase 4
Recruiting NCT05271448 - Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography N/A
Withdrawn NCT03806725 - Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography
Completed NCT04163250 - Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography