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Erythropoiesis-Stimulating Agent

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

Phase 2
Waitlist Available
Led By Rajiv Agarwal, MD MBBS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Controlled hypertension with 24 hour ambulatory blood pressure monitoring less than 140/90 mmHg at baseline and treatment with at least 1 antihypertensive medication
Stage 3 or 4 chronic kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks vs 12 weeks to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether erythropoietin (EPO) therapy can raise diastolic blood pressure in anemic patients with chronic kidney disease. The study will measure the effects of EPO therapy at 12 weeks after treatment, and will enroll 160 subjects.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include increased diastolic blood pressure due to EPO therapy. The procedure involves fasting blood draws, ambulatory BP monitoring, urine collection, and forearm blood flow tests which carry minimal risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My high blood pressure is under control with medication and is below 140/90 mmHg.
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My kidney disease is in stage 3 or 4.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks vs 12 weeks to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks vs 12 weeks to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Change in flow mediated dilatation (FMD)
Predictors of change in flow mediated dilatation (FMD)
Secondary study objectives
Between group change in hypertension status
Change in systolic blood pressure in EPO treated patients
Within group change in hypertension status

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,644 Total Patients Enrolled
Rajiv Agarwal, MD MBBSPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN

Media Library

Darbepoetin (Erythropoiesis-Stimulating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03810911 — Phase 2
Chronic Kidney Disease Research Study Groups: Early start, Delayed start
Chronic Kidney Disease Clinical Trial 2023: Darbepoetin Highlights & Side Effects. Trial Name: NCT03810911 — Phase 2
Darbepoetin (Erythropoiesis-Stimulating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03810911 — Phase 2
~0 spots leftby Dec 2024
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