Back to resultsRenoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
Primary Purpose
Chronic Kidney Disease stage3, Contrast-induced Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Isotonic saline
N-acetyl cysteine
Febuxostat 80 MG
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease stage3
Eligibility Criteria
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 .
Sites / Locations
- Ain shams university hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control arm
Febuxostat arm
Arm Description
This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).
This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .
Outcomes
Primary Outcome Measures
prevention of CI-AKI
incidence of CI-AKI after 48-72 hours after PCI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05264584
Brief Title
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
Official Title
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage3, Contrast-induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control arm
Arm Type
Other
Arm Description
This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).
Arm Title
Febuxostat arm
Arm Type
Experimental
Arm Description
This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Other Intervention Name(s)
Saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Febuxostat 80 MG
Other Intervention Name(s)
Feburic 80
Intervention Description
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.
Primary Outcome Measure Information:
Title
prevention of CI-AKI
Description
incidence of CI-AKI after 48-72 hours after PCI
Time Frame
48-72 hours post contrast
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Saad, Bachelor
Organizational Affiliation
Faculty of medicine Ain shams university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iman Sarhan, PhD
Organizational Affiliation
Faculty of medicine Ain Shams university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nahla Teama, PhD
Organizational Affiliation
Faculty of medicine Ain Shams university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yasser Alaa, PhD
Organizational Affiliation
Faculty of medicine Ain Shams university
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university hospitals
City
Cairo
ZIP/Postal Code
1181
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
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