NCT01066351

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 10, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

February 9, 2010

Last Update Submit

February 9, 2010

Conditions

Acute Renal Failure

Keywords

acute kidney injuryerythropoietincardiac surgery

Outcome Measures

Primary Outcomes (1)

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

    1.5 year

Secondary Outcomes (1)

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

    1.5 year

Study Arms (2)

Erythropoietin

EXPERIMENTAL

The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.

Drug: beta erythropoietin

placebo

PLACEBO COMPARATOR

The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Drug: placebo

Interventions

beta erythropoietinDRUG

The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.

Also known as: Recormon
Erythropoietin
placeboDRUG

The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Also known as: normal saline
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 surgery.
  • receiving erythropoietin within 14 days before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adis Tasanarong

Khlong Luang, Pathumtani, 12121, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 19494484BACKGROUND

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

    PMID: 19077684BACKGROUND

  • 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.

    PMID: 19005302BACKGROUND

  • Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

    PMID: 39301879DERIVED

  • Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.

    PMID: 23829828DERIVED

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

epoetin betaSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Adis Tasanarong, MD

    Thammasat Universuty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

February 10, 2010

Record last verified: 2010-01

Locations

TH(1)