The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

NCT ID: NCT03102021

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

erythropoeitin

Group Type ACTIVE_COMPARATOR

erythropoietin

Intervention Type DRUG

500 units/kg daily for 3 days at onset of acute kidney injury

2

saline placebo

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

saline 10 ml for 3 days

Interventions

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erythropoietin

500 units/kg daily for 3 days at onset of acute kidney injury

Intervention Type DRUG

saline

saline 10 ml for 3 days

Intervention Type DRUG

Other Intervention Names

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erythropoeitin normal saline

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Devasmita Dev, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Devasmita Dev, MD

Role: PRINCIPAL_INVESTIGATOR

DAllas VA Medical Center/UT Southwestern Medical Center

Locations

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Dallas VAMC

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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092006-064 - UTSW protocol ID

Identifier Type: -

Identifier Source: secondary_id

#05-141

Identifier Type: -

Identifier Source: org_study_id

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