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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05264584

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease stage3 Contrast-induced Nephropathy	Drug: Isotonic saline Drug: N-acetyl cysteine Drug: Febuxostat 80 MG	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: control arm This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).	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. Other Names: Saline Drug: 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 . Other Names: NAC
Experimental: Febuxostat arm This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .	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. Other Names: Saline Drug: 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 . Other Names: NAC Drug: 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. Other Names: Feburic 80

Arm

Intervention/Treatment

Other: control arm

This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm).

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.

Other Names:

Saline

Drug: 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 .

Other Names:

NAC

Experimental: Febuxostat arm

This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat .

Drug: Isotonic saline

Other Names:

Saline

Drug: 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 .

Other Names:

NAC

Drug: Febuxostat 80 MG

Other Names:

Feburic 80

Outcome Measures

Primary Outcome Measures

prevention of CI-AKI [48-72 hours post contrast]
incidence of CI-AKI after 48-72 hours after PCI

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams university hospitals	Cairo		Egypt	1181

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Rania Saad, Bachelor, Faculty of medicine Ain shams university
Study Director: Iman Sarhan, PhD, Faculty of medicine Ain Shams university
Study Chair: Nahla Teama, PhD, Faculty of medicine Ain Shams university
Study Chair: Yasser Alaa, PhD, Faculty of medicine Ain Shams university