drugset / Trial / NCT03810911

Mechanisms of EPO-induced Hypertension

NCT03810911

Phase 2 Terminated 27 enrolled VA Office of Research and Development
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2021-01-04
Primary completion
2024-12-31
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic