Prevention of Contrast Induced Nephropathy by Erythropoietin

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western Galilee Hospital-Nahariya
• Treatments: Epoetin Alfa

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.