The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

Acute Kidney Injury Clinical Trial

Official title:

The Effect of High Dose Erythropoietin in Acute Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102021
• Other study ID #: #05-141
• Secondary ID: 092006-064 - UTS
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: March 30, 2017
• Start date: March 2006
• Est. completion date: June 2013

Study information

• Verified date: March 2017
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency

Intervention

Drug:
• erythropoietin
500 units/kg daily for 3 days at onset of acute kidney injury
• saline
saline 10 ml for 3 days

Locations

Country	Name	City	State
United States	Dallas VAMC	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days of acute renal failure		28 days
Secondary	days of hospitalization		60 days