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NCT02064426 · ClinicalTrials.gov registry record · Phase 2

Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

A Phase 2 study of Anemia and Renal Insufficiency, Chronic, sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target
20
Study locations

NCT02064426 is a Phase 2 study of Anemia and Renal Insufficiency, Chronic that has completed, run by Bayer. The registered enrollment target is 88 participants, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT02064426, a Phase 2 study of Anemia and Renal Insufficiency, Chronic, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target
20
Study locations

Study Summary

Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.

Conditions Studied

Anemia Renal Insufficiency, Chronic

Interventions

  • DRUG Molidustat (BAY85-3934)
  • BIOLOGICAL Epoetin alfa/beta

Study Locations (20)

California

  • - Azusa
  • - Long Beach
  • - Lynwood
  • - Northridge
  • - San Dimas
  • - Whittier
  • - Whittier

Texas

  • - Fort Worth
  • - Fort Worth
  • - Fort Worth
  • - Grand Prairie

Florida

  • - New Port Richey
  • - Pembroke Pines

Ohio

  • - Cincinnati
  • - Toledo

Michigan

  • - Detroit

Missouri

  • - Creve Coeur

New York

  • - Buffalo

Oklahoma

  • - Oklahoma City

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2014-03-13
Est. Completion 2016-11-16
Phase Phase 2

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT02064426

The ClinicalTrials.gov registry entry for NCT02064426 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (79% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Molidustat (BAY85-3934) is the first listed.

NCT02064426 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT02064426 about?

NCT02064426 is a clinical study titled "Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934". Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.

What is the current status of trial NCT02064426?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2014-03-13. Estimated completion is 2016-11-16.

What conditions does trial NCT02064426 study?

This clinical trial studies the following conditions: Anemia, Renal Insufficiency, Chronic.

What interventions are being tested in trial NCT02064426?

The interventions under investigation include: Molidustat (BAY85-3934) (DRUG), Epoetin alfa/beta (BIOLOGICAL).

Who is sponsoring clinical trial NCT02064426?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02064426 being conducted?

This trial has 20 study locations across California, Florida, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.