Prevention of Contrast Induced Nephropathy by Erythropoietin
NCT ID: NCT01364402
Last Updated: 2012-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
142 participants
INTERVENTIONAL
2011-08-31
2013-12-31
Brief Summary
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The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.
Detailed Description
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The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Erythropoietin
Epoetin beta
50,000U intravenously
Placebo
Saline 0.9%
normal saline intravenously
Interventions
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Epoetin beta
50,000U intravenously
Saline 0.9%
normal saline intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetic patients.
* eGFR \< 60 ml/min/1.73m2.
* Scheduled for primary or elective PCI.
Exclusion Criteria
* Patients with eGFR ≥ 60 ml/min/1.73m2.
* Chronic renal replacement therapy.
* Subject with active malignancy.
* Subject with any known history of seizure disorders.
* Subject with polycythemia.
* Uncontrolled hypertension.
* Known allergy or hypersensitivity to EPO.
* Use of EPO 1 week prior to randomization.
* Use of long acting EPO (CERA) during 1 month prior to randomization.
* Use of NAC or bicarbonate during 3 days prior to randomization.
* Contrast media exposure during the last 7 days before randomization.
* Pregnant or lactating women.
* Participation in other clinical trial.
* Refusal or inability to give informed consent due to mental or physical state.
18 Years
ALL
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Western Galilee Hospital
Principal Investigators
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Shaul Atar, MD
Role: PRINCIPAL_INVESTIGATOR
Western Galilee Hospital
Locations
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Western Galilee Hospital
Nahariya, , Israel
Countries
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Central Contacts
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Facility Contacts
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Shaul Atar, MD
Role: primary
Batya Kristal, MD
Role: backup
References
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Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.
Other Identifiers
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EPO1
Identifier Type: -
Identifier Source: org_study_id