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Erythropoietin Role in Acute Kidney Injury (EAKI)

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ClinicalTrials.gov Identifier: NCT03401710
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mabel Aoun, Saint-Joseph University

Brief Summary:

The use of erythropoietin to treat anemia in acute kidney injury (AKI) is controversial. No previous clinical trial has assessed the possible reduction of transfusions when erythropoietin is started very early in a setting of in-hospital acute kidney injury.

This randomised multicenter pragmatic clinical trial will compare the need for transfusion in acute kidney injury between two groups: group 1 will receive erythopoietin 4000 UI every other day and group 2 the usual treatment.


Condition or disease Intervention/treatment Phase
Anemia Renal Drug: Erythropoietin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erythropoietin Role in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Group 1
Recombinant human erythropoietin 4000 UI will be administered subcutaneously every other day
Drug: Erythropoietin
Erythropoietin 4000 UI will be administered every other day subcutaneously
Other Name: No treatment

No Intervention: Group 2
No recombinant human erythropoietin will be administered to this group



Primary Outcome Measures :
  1. Transfusion [ Time Frame: Admission- One month ]
    Number of red blood cell transfusions


Secondary Outcome Measures :
  1. Renal survival [ Time Frame: Admission - One month ]
    Creatinine level at discharge

  2. Mortality [ Time Frame: Admission - One month ]
    Death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients > 18 years old hospitalized with acute kidney injury and anemia

Exclusion Criteria:

  • pregnant women, terminally ill patients, patients with major or minor thalassemia, patients with stable chronic kidney disease or patients on dialysis and patients who were receiving rHuEPO or any erythropoiesis-stimulating agent (ESA) before admission.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401710


Contacts
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Contact: Mabel Aoun, MD 009613351588 mabel.aoun@usj.edu.lb
Contact: Ghassan Sleilaty, MD

Locations
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Lebanon
Saint Georges Hospital Recruiting
Aajaltoûn, Ajaltoun, Lebanon
Contact: Mabel Aoun, MD    09234201 ext 1111    mabel.aoun@usj.edu.lb   
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Mabel Aoun, MD Saint-Joseph University

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Responsible Party: Mabel Aoun, MD, instructor, nephrology department, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT03401710     History of Changes
Other Study ID Numbers: EAKI2017
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mabel Aoun, Saint-Joseph University:
Anemia, Acute Kidney injury, ESA, Erythropoietin

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics