Mechanisms of EPO-induced Hypertension

Stopped early · Phase 2

Conditions studied: Chronic Kidney Disease, Blood Pressure, Anemia

In brief

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.

Key facts

Study ID

NCT03810911

Run by

VA Office of Research and Development

People needed

27

Starts

2021-01-04

Expected to finish

2025-07-31

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage 3 or 4 chronic kidney disease
• Controlled hypertension with 24 hour ambulatory blood pressure monitoring less than 140/90 mmHg at baseline and treatment with at least 1 antihypertensive medication
• Hemoglobin between 8 and 10 g/dL
• No treatment with erythropoiesis-stimulating agents (ESA) within 3 previous months

You may not qualify if…

• Need for packed red blood cells (RBC) transfusion in the previous 2 months
• Myocardial infarction, stroke or hospitalization for heart failure in the past 2 months
• In the assessment of the investigator, have hematologic, inflammatory, infectious, or other conditions that might interfere with the erythropoietic response

Where it is running

• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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