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Outcome Measures

Primary Outcomes (1)

Change in Carotid Total Plaque Volume From Baseline to Approximately 1 Year, as Assessed by Non-contrast MRI
The plaque characteristics will be analyzed by MRI-PlaqueViewTM (VP diagnostics Inc., WA). Planimetry will be performed on the image data sets, using histogram equalization to improve edge detection for plaque, arterial wall and lumen. Differences in image contrast between T1-weighted, T2-weighted, Time of Flight, and proton density will be used to characterize the plaque as fibrous, stable, or unstable.
1 year

Secondary Outcomes (3)

Severity of Maximal Stenosis at Baseline and Upon Follow-up.
1 year
Percentage of Total Plaque Area at Baseline and Upon Follow-up.
1 year

Study Arms (2)

Low dose erythropoietin

PLACEBO COMPARATOR

Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly

Drug: Low dose erythropoietin

High dose erythropoietin

EXPERIMENTAL

Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks

Drug: High dose erythropoietin

Interventions

Low dose erythropoietinDrug

Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly

Also known as: Low dose

Low dose erythropoietin

High dose erythropoietinDrug

Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The investigators will enroll Veterans who fulfill the following criteria:
stage 3, 4, or 5 CKD (estimated glomerular filtration rate of less than 60 ml/min/1.73 m2) on at least two separate occasions greater than 3 months apart; and

MeSH Terms

Conditions

AnemiaAtherosclerosis

Interventions

ErythropoietinContraceptives, Oral

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugates

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

The outcome is the progression of carotid plaque. John Forder, PhD, who will read the MRIs will be blinded to the subject and treatment group.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: Patients will be randomly assigned two different erythropoietin dosing strategies. One group will be given more frequent, low-doses of EPO and the other group will be given the same, cumulative dose given every 2 weeks.

Sponsor Type

FED

Responsible Party

SPONSOR

Study Stopped

Frequent, Low-Dose Erythropoietin A Mechanistic Approach to Mitigate Adverse Cardiovascular Effects of Erythropoietin

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Low dose erythropoietin

High dose erythropoietin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations