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Prevention of Contrast Induced Nephropathy by Erythropoietin

This study is currently recruiting participants.
Verified September 2011 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01364402
First received: May 24, 2011
Last updated: October 9, 2012
Last verified: September 2011
History of Changes
  Purpose

This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.

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.


Condition Intervention Phase
Diabetes
Chronic Kidney Insufficiency
 Drug: Epoetin beta
Drug: Saline 0.9%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Incidence of Contrast Induced Nephropathy(CIN) [ Time Frame: 1-3 days after exposure to contrast media ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Enzymatic infarct size [ Time Frame: 6h and 12 h after exposure to contrast media ] [ Designated as safety issue: No ]
    Will be measured by Troponin and CK

  • Hospital length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
  • Renal replacement therapy [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin Drug: Epoetin beta
50,000U intravenously
Other Name: Epoietin beta
Placebo Comparator: Placebo Drug: Saline 0.9%
normal saline intravenously
Other Name: Hydration

Detailed Description:

Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age.
  • Diabetic patients.
  • eGFR < 60 ml/min/1.73m2.
  • Scheduled for primary or elective PCI.

Exclusion Criteria:

  • Non diabetic patients.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364402

Contacts
Contact: Lilach Shema-Didi, RN, MPH 972-507887538 lilach_01@yahoo.com
Contact: Lilach Shema-Didi, RN, MPH Lilach.Shema-Didi@naharia.health.gov.il

Locations
Israel
Western Galilee Hospital Recruiting
Nahariya, Israel
Contact: Shaul Atar, MD         shaul.atar@naharia.health.gov.il    
Contact: Batya Kristal, MD         batya.kristal@naharia.health.gov.il    
Principal Investigator: Shaul Atar, MD            
Principal Investigator: Batya Kristal, MD            
Sub-Investigator: Lilach Shema-Didi, RN, MPH            
Sub-Investigator: Irith Weissman, MD            
Sub-Investigator: Ronit Geron, MD            
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Shaul Atar, MD Western Galilee Hospital
  More Information

No publications provided

Responsible Party: Dr. Shaul Atar, Western Galilee Hospital
ClinicalTrials.gov Identifier: NCT01364402     History of Changes
Other Study ID Numbers: EPO1
Study First Received: May 24, 2011
Last Updated: October 9, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:
scheduled for PCI

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013