Prevention of Contrast Induced Nephropathy by Erythropoietin

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364402
• Other study ID #: EPO1
• Status: Recruiting
• Phase: Phase 3
• First received: May 24, 2011
• Last updated: October 9, 2012
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2011
• Source: Western Galilee Hospital-Nahariya
• Contact: Lilach Shema-Didi, RN, MPH
• Phone: 972-507887538
• Email: lilach_01[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Insufficiency
• Diabetes
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin beta
50,000U intravenously
• Saline 0.9%
normal saline intravenously

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Contrast Induced Nephropathy(CIN)		1-3 days after exposure to contrast media	No
Secondary	Enzymatic infarct size	Will be measured by Troponin and CK	6h and 12 h after exposure to contrast media	No
Secondary	Hospital length of stay		participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Renal replacement therapy		participants will be followed after PCI procedure till discharge, an expected average of 1-2 days	No
Secondary	Hospital mortality		participants will be followed after PCI procedure till discharge, an expected average of 1-2 days	No