The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

Phase 2

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: erythropoietin; Drug: saline

• Registration Number: NCT03102021
• Lead Sponsor: North Texas Veterans Healthcare System

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

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-12-26
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Study First Posted: 2017-04-05
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	erythropoietin	erythropoeitin
2	saline	saline placebo

Primary Outcome Measures

Name	Time	Method
days of acute renal failure	28 days

Secondary Outcome Measures

Name	Time	Method
days of hospitalization	60 days

Trial Locations

Locations (1)

Dallas VAMC; 🇺🇸 Dallas, Texas, United States