Study of Erythropoietin (EPO) Administration Schedule

May 12, 2014 updated by: JW Pharmaceutical

Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis

The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 80.
  • Dialysis for at least 3 months.
  • Epoetin treatment for the last 3 months.
  • Baseline hemoglobin (Hb) value of >= 9.0 g/dL and < 13.0 g/dL.
  • Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
  • Patients who agree to participate in this study in writing.

Exclusion Criteria:

  • Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
  • Hemolysis as defined
  • Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
  • Patients with uncontrolled hypertension.
  • Acute infection of unstable systemic inflammatory disease.
  • Current malignant disease.
  • High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
  • Life expectancy below 12 months.
  • Planned elective surgery during the study period.
  • Blood transfusions within the last 3 months.
  • Pregnancy and lactation.
  • Other conditions regarded as unsuitability by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: once weekly
Drug: recomon (Epoetin Beta)
administer once weekly
Drug: recomon (Epoetin Beta)
administer three times weekly
Active Comparator: three times weekly
Drug: recomon (Epoetin Beta)
administer once weekly
Drug: recomon (Epoetin Beta)
administer three times weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The hemoglobin variability between once & three times weekly administration
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The hematocrit variability between once & three times weekly administration
Time Frame: 24 weeks
24 weeks
Mean value of Hb and Hct between once & three times weekly administration
Time Frame: 24 weeks
24 weeks
Drop out rate during dose fix period
Time Frame: 24 weeks
24 weeks
Mean value of Hb and Hct during dose fix period
Time Frame: 24 weeks
24 weeks
Variability of Hb and Hct during dose fix period
Time Frame: 24weeks
24weeks
Weekly oetin-beta maintenance dose between once & three times weekly administration
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: SugKyun Shin, Ph.D., National Health Insurance Service Ilsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 25, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP_RCM_R01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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