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The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erythropoietin
saline
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dallas VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

erythropoeitin

saline placebo

Outcomes

Primary Outcome Measures

days of acute renal failure

Secondary Outcome Measures

days of hospitalization

Full Information

First Posted
December 26, 2007
Last Updated
March 30, 2017
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03102021
Brief Title
The Effect of Human Recombinant Erythropoietin in Acute Renal Failure
Official Title
The Effect of High Dose Erythropoietin in Acute Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
erythropoeitin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
saline placebo
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
erythropoeitin
Intervention Description
500 units/kg daily for 3 days at onset of acute kidney injury
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
normal saline
Intervention Description
saline 10 ml for 3 days
Primary Outcome Measure Information:
Title
days of acute renal failure
Time Frame
28 days
Secondary Outcome Measure Information:
Title
days of hospitalization
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devasmita Dev, MD
Organizational Affiliation
DAllas VA Medical Center/UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VAMC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

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