Erythropoietin in Hemolytic Uremic Syndrome

January 11, 2021 updated by: Alejandro Balestracci, Hospital General de Niños Pedro de Elizalde

Effect of Erythropoietin on Red Blood Cell Requirement in Children With Hemolytic Uremic Syndrome: a Randomized Controlled Trial

This study will evaluate the impact of early administration of erythropoietin in the number of red blood cell transfusions in children with Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Anemia in STEC-HUS is treated with red blood cell (RBC) transfusions. It can causes hypervolemia, hyperkalemia, exacerbate the thrombotic state of the disease, transmit infectious agents and trigger antigenic sensitization. Anemia is mainly due to hemolysis, but deficit of erythropoietin synthesis (EPO) may aggravate it. Although recombinant human EPO is frequently used in children with STEC-HUS there is no adequate evidence of its benefit. If it is confirmed that EPO reduce the number of RBC transfusions, its administration could diminish the aforementioned risks and also reduce costs.

Objective:

To determine if EPO administration decreases the number of RBC transfusions and; secondarily, to assess if its levels influence on transfusion requirement.

Methodology:

Randomized, open controlled clinical trial. We will include 28 patients (14 per arm) <18 years with STEC-HUS admitted to our hospital. They will be grouped after randomization:(1) One to standard of care (RBC transfusions with hemoglobin ≤7 mg / dl and/or hemodynamic instability) and (2) the other to standard of care plus EPO (50 u / kg subcutaneous three times weekly) and RBC transfusions with hemoglobin ≤7 mg / dl). Serum EPO will be measured by ELISA and together with the clinical and laboratory variables, association with RBC transfusions number will be sought. Written informed consent and assent when appropriate, will be requested prior to enter into the study.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post diarrheal HUS: Prodrome of enteritis followed by microangiopathic hemolytic anemia, thrombocytopenia and signs of renal damage (increased plasma creatinine, proteinuria, and / or hematuria). Proven STEC infection wiil not be required to enter into the study.

Exclusion Criteria:

  • Atypical HUS
  • HUS associated with systemic diseases (pneumococcal infection, HIV, Systemic lupus erythematosus) or drugs
  • Anemia or known kidney disease
  • Previously transfused or treated with erythropoietin
  • Contraindications to erythropoietin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin
Erythropoietin plus standard of care (RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability)
Drug: erythropoietin
erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route
Other Names:
  • EPO
No Intervention: No Intervention
Standard of care: RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of RBC transfusions
Time Frame: At the end of the 36 month study recruiting period
To determine if administration of erythropoietin decreases the number of RBC during the acute stage of hemolytic uremic syndrome
At the end of the 36 month study recruiting period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythropoietin levels
Time Frame: At the end of the 36 month study recruiting period
To determine if erythropoietin levels correlate with RBC transfusions requirement.
At the end of the 36 month study recruiting period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Niños Pedro de Elizalde

Investigators

  • Principal Investigator: Alejandro Balestracci, MD, PhD, Hospital General de Niños Pedro de Elizalde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 347-HGNPE-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The authors will share the generated data with qualified external researchers during the next 5 years after article publication. All data provided will be anonymized to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.

IPD Sharing Time Frame

During the next 5 years after article publication.

IPD Sharing Access Criteria

Qualified external researchers

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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