Chronic Kidney Disease stage3NCT05264584
Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
A study testing Isotonic saline, N-acetyl cysteine and Febuxostat 80 MG in people with Chronic Kidney Disease stage3 and Contrast-induced Nephropathy, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease stage3, Contrast-induced Nephropathy
- What is being tested?
- Isotonic saline, N-acetyl cysteine and Febuxostat 80 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Isotonic saline, N-acetyl cysteine, Febuxostat 80 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic salineDrug
Also called 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 cysteineDrug
Also called NAC
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 MGDrug
Also called Feburic 80
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.
| Study group | Role | What they receive |
|---|---|---|
| control arm | Other | This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm). Receives: Drug: Isotonic saline; Drug: N-acetyl cysteine |
| Febuxostat arm | Experimental | This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat . Receives: Drug: Isotonic saline; Drug: N-acetyl cysteine; Drug: Febuxostat 80 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of CI-AKI
incidence of CI-AKI after 48-72 hours after PCI
Measured: 48-72 hours post contrast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania Saad, Bachelor, Principal investigator, Faculty of medicine Ain shams universityIman Sarhan, PhD, Study director, Faculty of medicine Ain Shams universityNahla Teama, PhD, Study chair, Faculty of medicine Ain Shams universityYasser Alaa, PhD, Study chair, Faculty of medicine Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264584
- Sponsor's protocol ID
- MS 616/2020
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3
- ClinicalTrials.gov ID
- NCT05264584
- Acronym / sponsor ID
- MS 616/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | Other | Drug: Isotonic saline, Drug: N-acetyl cysteineThis arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm). |
| Febuxostat arm | Experimental | Drug: Isotonic saline, Drug: N-acetyl cysteine, Drug: Febuxostat 80 MGThis arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotonic salineAlso: SalineAll 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. | Drug | Febuxostat arm, control arm |
| N-acetyl cysteineAlso: NACall 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 . | Drug | Febuxostat arm, control arm |
| Febuxostat 80 MGAlso: Feburic 80All 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. | Drug | Febuxostat arm |
Primary outcome
prevention of CI-AKI
Time frame: 48-72 hours post contrast
incidence of CI-AKI after 48-72 hours after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Saad, Bachelor principal investigator
Faculty of medicine Ain shams university
Iman Sarhan, PhD study director
Faculty of medicine Ain Shams university
Nahla Teama, PhD study chair
Faculty of medicine Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic saline, N-acetyl cysteine and Febuxostat 80 MG in people with Chronic Kidney Disease stage3 and Contrast-induced Nephropathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of CI-AKI (time frame: 48-72 hours post contrast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.