Erythropoietin Role in Acute Kidney Injury

NCT03401710 | Terminated

• 1 other identifier: EAKI2017
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia Renal

Keywords

Anemia, Acute Kidney injury, ESA, Erythropoietin

Outcome Measures

Primary Outcomes (1)

• Transfusion

  Number of red blood cell transfusions

  Admission- One month

Secondary Outcomes (2)

• Renal survival

  Admission - One month

• Mortality

  Admission - One month

Study Arms (2)

Group 1

EXPERIMENTAL

Recombinant human erythropoietin 4000 UI will be administered subcutaneously every other day

Drug: Erythropoietin

Group 2

NO INTERVENTION

No recombinant human erythropoietin will be administered to this group

Interventions

Erythropoietin DRUG

Erythropoietin 4000 UI will be administered every other day subcutaneously

Also known as: No treatment

Group 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Georges Hospital

Ajaltoun, Ajaltoun, Lebanon

Location

Related Publications (1)

• Aoun M, Sleilaty G, Boueri C, Younes E, Gabriel K, Kahwaji RM, Hilal N, Hawi J, Araman R, Chelala D, Beaini C. Erythropoietin in Acute Kidney Injury (EAKI): a pragmatic randomized clinical trial. BMC Nephrol. 2022 Mar 13;23(1):100. doi: 10.1186/s12882-022-02727-5.

  PMID: 35279078 DERIVED

MeSH Terms

Conditions

Anemia; Acute Kidney Injury

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mabel Aoun, MD

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, instructor, nephrology department

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 17, 2018
• Study Start: April 16, 2018
• Primary Completion: March 20, 2021
• Study Completion: August 25, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

LE (1)