Darbepoetin for High Blood Pressure in Chronic Kidney Disease
(EPIC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRajiv Agarwal, MD MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rajiv Agarwal, MD MBBS

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Eligibility Criteria

This trial is for anemic patients with stage 3 or 4 chronic kidney disease who have a hemoglobin level between 8 and 10 g/dL, haven't used erythropoiesis-stimulating agents recently, and have controlled high blood pressure treated with medication. It's not for those who've had recent heart issues or transfusions, or other conditions affecting red blood cell production.

Inclusion Criteria

My high blood pressure is under control with medication and is below 140/90 mmHg.

I haven't taken any drugs to increase red blood cells in the last 3 months.

Your hemoglobin level is between 8 and 10 grams per deciliter.

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Exclusion Criteria

I have not had a heart attack, stroke, or been hospitalized for heart failure in the last 2 months.

You have a medical condition that might affect how your body makes red blood cells.

I needed a blood transfusion in the last 2 months.

Treatment Details

Interventions

Darbepoetin (Erythropoiesis-Stimulating Agent)

Trial OverviewThe study tests if EPO therapy raises diastolic blood pressure in anemic patients with chronic kidney disease over a period of 12 weeks. It will also examine the relationship between this potential increase and changes in endothelial function as well as forearm blood flow response to oxygen.

Participant Groups

2Treatment groups

Active Control

Group I: Early startActive Control1 Intervention

Participants given study drug immediately at randomization

Group II: Delayed startActive Control1 Intervention

Participants given study drugs 12 weeks after randomization