ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Human Recombinant Erythropoietin in Acute Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03102021
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Devasmita Dev, MD, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: erythropoietin Drug: saline Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of High Dose Erythropoietin in Acute Renal Failure
Study Start Date : March 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
erythropoeitin
Drug: erythropoietin
500 units/kg daily for 3 days at onset of acute kidney injury
Other Name: erythropoeitin

Placebo Comparator: 2
saline placebo
Drug: saline
saline 10 ml for 3 days
Other Name: normal saline




Primary Outcome Measures :
  1. days of acute renal failure [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. days of hospitalization [ Time Frame: 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102021


Locations
United States, Texas
Dallas VAMC
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Devasmita Dev, MD DAllas VA Medical Center/UT Southwestern Medical Center

Responsible Party: Devasmita Dev, MD, Principal Investigator, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT03102021     History of Changes
Other Study ID Numbers: #05-141
092006-064 - UTSW protocol ID
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics