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Completed

NCT Number: NCT03102021

The Effect of Human Recombinant 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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dallas VAMC

Dallas, Texas, 75216, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

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

Other names: erythropoeitin

Saline

Drug

saline 10 ml for 3 days

Other names: normal saline

Primary outcomes

  1. days of acute renal failure

    Time frame: 28 days

Secondary outcomes

  1. days of hospitalization

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Official study title

The Effect of High Dose Erythropoietin in Acute Renal Failure

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2017
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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