Prevention of Contrast Induced Nephropathy by Erythropoietin

Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Chronic Kidney Insufficiency
• Intervention / Treatment: Drug: Epoetin beta; Drug: Saline 0.9%

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.

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Recruiting
    • Western Galilee Hospital
    • Contact: Shaul Atar, MD; Email: shaul.atar@naharia.health.gov.il
    • Contact: Batya Kristal, MD; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Saline 0.9%; normal saline intravenously; Other Names: Hydration
Experimental: Erythropoietin	Drug: Epoetin beta; 50,000U intravenously; Other Names: Epoietin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Contrast Induced Nephropathy(CIN)	1-3 days after exposure to contrast media

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enzymatic infarct size	Will be measured by Troponin and CK	6h and 12 h after exposure to contrast media
Hospital length of stay		participants will be followed for the duration of hospital stay, an expected average of 3 days
Renal replacement therapy		participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Hospital mortality		participants will be followed after PCI procedure till discharge, an expected average of 1-2 days

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Shaul Atar, MD, Western Galilee Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: scheduled for PCI
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Hematinics; Epoetin Alfa
• Other Study ID Numbers: EPO1