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Mechanisms of EPO-induced Hypertension

NCT03810911 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-15

Study results available
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Summary

The investigators hypothesize that compared to untreated controls, erythropoietin (EPO) therapy in anemic patients with chronic kidney disease will raise diastolic blood pressure (BP). The magnitude of increase in diastolic BP at 12 weeks after treatment will be related to two factors. First, endothelial dysfunction and worsening of endothelial function from baseline to 4 weeks and second, the change of forearm blood flow in response to breathing oxygen and the change in this measure from baseline to 4 weeks. Study procedures include fasting blood draws, ambulatory blood pressure, urine collection, and forearm blood flow tests. The study hopes to accrue 160 subjects.

Conditions

Interventions

DRUG

Darbepoetin

Used to treat anemia. In the group labeled no intervention, the intervention is simply delayed 12 weeks after randomization as noted in the description.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Rajiv Agarwal, MD MBBS · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2024-12-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03810911 on ClinicalTrials.gov