Mechanisms of Erythropoietin Induced Hypertension

NEPH-005-18S

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.

2021-01-04

2024-12-31

2025-07-31

Active (not recruiting)

Early phase I

27

Inclusion Criteria: * 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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'All subjects will receive darbepoetin during the study. One group, the immediate start group, will receive the drug the day of randomization. The other group, the delayed start group, will receive the drug 12 weeks later.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The groups are randomized not the study drug. The groups will be known by both the participant and the investigator.'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

2024-03-12