Contrast-induced NephropathyPhase 2CI-AKINCT03767322
Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
A Phase 2 study testing Allopurinol and Febuxostat in people with Contrast-induced Nephropathy and Contrast-induced Acute Kidney Injury, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Contrast-induced Nephropathy, Contrast-induced Acute Kidney Injury
- What is being tested?
- Allopurinol and Febuxostat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 1 siteMexico
- Study dates
- 5 Dec 2018to Dec 2019
- Phase
- Phase 2
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, México City
Magdalena Madero, MD, 015255 5573 2911 ext. 21425, madero.magdalena@gmail.com
Salvador Lopez-Gil, MD, 015255 5573 2911 ext. 21425, salvadorlgil@gmail.com
About this study
A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)
Read the 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
- Being tested
- Allopurinol, Febuxostat, Placebo
- Keywords
- contrast induced acute kidney injury, contrast induced nephropathy, allopurinol, febuxostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Zyloprim
Eligible patients will receive allopurinol 300 mg before and after coronary intervention
FebuxostatDrug
Also called Turazive
Eligible patients will receive febuxostat 80 mg before and after coronary intervention
PlaceboDrug
Eligible patients will receive before and after coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol group | Active comparator | The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention. Receives: Drug: Allopurinol |
| Placebo group | Placebo comparator | The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention. Receives: Drug: Placebo |
| Febuxostat group | Active comparator | The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention Receives: Drug: Febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of contrast induced acute kidney injury
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
Measured: 48 hours
Secondary outcomes (2)
Renal replacement therapy requirement
Initiation of renal replacement therapy
Measured: 7 days
Length of hospitalization
Length of hospitalization
Measured: 3 days to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start5 Dec 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- Salvador López Gil, Armando Vázquez Rangel
- Responsible party
- Principal investigator, Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Magdalena Madero, MD, Principal investigator, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767322
- Sponsor's protocol ID
- PT-18-081
- Acronym
- CI-AKI
- Status last verified
- Oct 2018
- First submitted
- 14 Oct 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
PubMed 28608311Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
PubMed 25653965Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
PubMed 27006404Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
PubMed 24942770Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
PubMed 25913922
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
- ClinicalTrials.gov ID
- NCT03767322
- Acronym / sponsor ID
- CI-AKI / PT-18-081
- Keywords
- contrast induced acute kidney injury, contrast induced nephropathy, allopurinol, febuxostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- Salvador López Gil, Armando Vázquez Rangel
- Study start
- 5 Dec 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Dec 2018 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allopurinol group | Active comparator | Drug: AllopurinolThe intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention. |
| Placebo group | Placebo comparator | Drug: PlaceboThe placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention. |
| Febuxostat group | Active comparator | Drug: FebuxostatThe intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| AllopurinolAlso: ZyloprimEligible patients will receive allopurinol 300 mg before and after coronary intervention | Drug | Allopurinol group |
| FebuxostatAlso: TuraziveEligible patients will receive febuxostat 80 mg before and after coronary intervention | Drug | Febuxostat group |
| PlaceboEligible patients will receive before and after coronary intervention | Drug | Placebo group |
Primary outcome
Prevention of contrast induced acute kidney injury
Time frame: 48 hours
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
2 secondary outcomes
Renal replacement therapy requirement
Time frame: 7 days
Length of hospitalization
Time frame: 3 days to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Background: PubMed 28608311Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
- Background: PubMed 25653965Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
- Background: PubMed 27006404Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
- Background: PubMed 24942770Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
- Background: PubMed 25913922Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
- Individual participant dataSharing planned: Undecided
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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.
Magdalena Madero, MD principal investigator
Instituto Nacional de Cardiologia Ignacio Chavez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol and Febuxostat in people with Contrast-induced Nephropathy and Contrast-induced Acute Kidney Injury, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Madero, MD (01 52 55 5573 2911 ext. 21425, madero.magdalena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of contrast induced acute kidney injury (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767322, which also lists 5 linked publications.
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 6 Dec 2018.