Mechanisms of EPO-induced Hypertension

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Stage 3 or 4 chronic kidney disease

• Controlled hypertension with 24 hour ambulatory blood pressure monitoring less than 130/80 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

Exclusion Criteria:

• 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