Skip to content

The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

The Effect of High Dose Erythropoietin in Acute Renal Failure

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03102021
Enrollment
25
Registered
2017-04-05
Start date
2006-03-31
Completion date
2013-06-30
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

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

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

Interventions

DRUGerythropoietin

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

DRUGsaline

saline 10 ml for 3 days

Sponsors

North Texas Veterans Healthcare System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
days of acute renal failure28 days

Secondary

MeasureTime frame
days of hospitalization60 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026