Prevention of Contrast Induced Nephropathy by Erythropoietin

Western Galilee Hospital-Nahariya

Status and phase: Unknown; Phase 3

Conditions: Diabetes; Chronic Kidney Insufficiency

Treatments: Drug: Epoetin beta; Drug: Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01364402

EPO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 2 patient groups, including a placebo group

Erythropoietin

Experimental group

Treatment:

Drug: Epoetin beta

Placebo

Placebo Comparator group

Treatment:

Drug: Saline 0.9%