The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

March 30, 2017 updated by: Devasmita Dev, MD, North Texas Veterans Healthcare System

The Effect of High Dose Erythropoietin in Acute Renal Failure

The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury is associated with increased morbidity. The most common injury to the kidney occurs during hospitalization with either ischemic or nephrotoxic insult to the kidney. This can prolong hospitalization and depending on the severity of the insult result in permanent decreased kidney function. Recent studies in animals have suggested benefits of using erythropoietin in high doses at time of kidney injury with eividence for less injury in the kidney tissue of those animals who received treatment compared to those animals that received only saline. Limited human data also suggests that use of high dose erythropoietin at the time of stroke can decrease the extent of brain injury. In addition cardiac cell culture studies also have shown decrease in cell injury with use of erythropoietin. These studies have prompted us to evaluate if admininstering erythropoietin to those with onset of acute kidney injury during their hospitalization may benefit from this intervention. This pilot study then evaluates that use of high dose erythropoietin administed daily over 3 days in patients with acute kidney injury on whether the days spent in renal failure are less than those who will receive no study medication. Those patients with kidney failure from either ischemic or nephrotoxic insult and no other contraindication to erythropoietin use will be considered for the study. Informed consent is obtained from the patient or next of kin

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

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

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VAMC

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age equal or greater than 21 yo
  • acute neprhotoxic or ischemic kidney injury, acute tubular necrosis

Exclusion Criteria:

  • no active or current malignancies
  • not actively receiveing epo
  • GFR less than 60 ml/min
  • unable to provide informed consent
  • contraindication to erythropoietin use

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
saline placebo
Drug: saline
saline 10 ml for 3 days
Other Names:
  • normal saline
Active Comparator: 1
erythropoeitin
Drug: erythropoietin
500 units/kg daily for 3 days at onset of acute kidney injury
Other Names:
  • erythropoeitin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
days of acute renal failure
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
days of hospitalization
Time Frame: 60 days
60 days

Collaborators and Investigators

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

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Principal Investigator: Devasmita Dev, MD, DAllas VA Medical Center/UT Southwestern Medical Center

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

March 1, 2006

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #05-141
  • 092006-064 - UTSW protocol ID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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