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Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

Information source: Thammasat University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Renal Failure

Intervention: beta erythropoietin (Drug); placebo (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Thammasat University

Official(s) and/or principal investigator(s):
Adis Tasanarong, MD, Principal Investigator, Affiliation: Thammasat Universuty


The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.

Clinical Details

Official title: Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

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

Primary outcome: The primary end-point of this study is the development of AKI in placebo group compared with EPO group.

Secondary outcome: The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups

Detailed description: Acute kidney injury (AKI)occur 7. 7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0. 7-3. 5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- age > 18 years.

- serum creatinine levels > 1. 2 mg/dL and baseline creatinine clearance levels < 60

mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)

- patients who need cardiac surgery

Exclusion Criteria:

- patients with acute kidney injury

- end stage renal disease (requiring dialysis)

- unstable renal function (as evidenced by a change in serum creatinine of > 0. 5 mg/dL,

or > 25%, within 14 days prior to the study)

- allergy to any of erythropoietin

- suffered from congestive heart failure, cardiogenic shock or emergent cardiac


- receiving erythropoietin within 14 days before the study

Locations and Contacts

Adis Tasanarong, Khlong Luang, Pathumtani 12121, Thailand
Additional Information

The Nephrology Society of Thailand

Toxicology data network

Related publications:

Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2.

Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. doi: 10.1097/MNH.0b013e32831a9dde. Review.

Bernhardt WM, Eckardt KU. Physiological basis for the use of erythropoietin in critically ill patients at risk for acute kidney injury. Curr Opin Crit Care. 2008 Dec;14(6):621-6. doi: 10.1097/MCC.0b013e328317ee82. Review.

Starting date: January 2010
Last updated: February 9, 2010

Page last updated: August 23, 2015

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