Status:
TERMINATED
Mechanisms of EPO-induced Hypertension
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Kidney Disease
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
Hypertension is a common but frequently overlooked and underreported adverse effect of erythropoietin (EPO) therapy. Recent trials have noted substantial cardiovascular risks associated with normaliza...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03810911
Start Date
January 4 2021
End Date
July 31 2025
Last Update
December 15 2025
Active Locations (1)
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1
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884