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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01364402
Other study ID # EPO1
Secondary ID
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


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
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