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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

EPIC Trial 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.Check my eligibility

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.See study design

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.

EPIC Trial 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.

EPIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks vs 12 weeks to 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Change in flow mediated dilatation (FMD)

Predictors of change in flow mediated dilatation (FMD)

Secondary outcome measures

Between group change in hypertension status

Change in systolic blood pressure in EPO treated patients

Within group change in hypertension status

EPIC 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,426 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

High Blood Pressure Research Study Groups: Early start, Delayed start

High Blood Pressure 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for prospective participants in this clinical trial?

"According to records on clinicaltrials.gov, this medical trial is currently recruiting suitable candidates. The initial post was published on April 1st 2021 and the information was most recently amended on January 21st 2022."

Answered by AI

Are there existing studies that have investigated the effectiveness of Early start?

"Presently, 6 clinical trials are being conducted to research Early start. Of these studies, 2 have advanced to Phase 3 and the majority of them are located in Albuquerque, New mexico. In total there are 29 locations running experiments with this drug."

Answered by AI

What risks do individuals face when utilizing Early start?

"Based on the limited information available due to it being in Phase 2, Early Start's safety was evaluated as a score of 2. There have been investigations into its security but no reports confirming efficacy yet."

Answered by AI

How many participants have been selected for this clinical experiment?

"Affirmative. The information on clinicaltrials.gov reveals that the investigation, which was initially launched on April 1st 2021, is actively recruiting individuals for participation. 160 participants are required from a single trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mechanisms of EPO-induced Hypertension

2021. "Mechanisms of EPO-induced Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03810911.

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