NCT03102021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

December 26, 2007

Last Update Submit

March 30, 2017

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • days of acute renal failure

    28 days

Secondary Outcomes (1)

  • days of hospitalization

    60 days

Study Arms (2)

1

ACTIVE COMPARATOR

erythropoeitin

Drug: erythropoietin

2

PLACEBO COMPARATOR

saline placebo

Drug: saline

Interventions

erythropoietinDRUG

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

Also known as: erythropoeitin
1
salineDRUG

saline 10 ml for 3 days

Also known as: normal saline
2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no active or current malignancies
  • not actively receiveing epo
  • GFR less than 60 ml/min
  • unable to provide informed consent
  • contraindication to erythropoietin use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VAMC

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

ErythropoietinSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Devasmita Dev, MD

    DAllas VA Medical Center/UT Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2007

First Posted

April 5, 2017

Study Start

March 1, 2006

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)