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The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

V

Veterans Affairs (VA) North Texas Health Care System

Status and phase

Completed
Phase 2

Conditions

Acute Kidney Injury

Treatments

Drug: saline
Drug: erythropoietin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03102021
#05-141
092006-064 - UTSW protocol ID

Details and patient eligibility

About

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.

Full 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

Enrollment

25 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

25 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
erythropoeitin
Treatment:
Drug: erythropoietin
2
Placebo Comparator group
Description:
saline placebo
Treatment:
Drug: saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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