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Study of Erythropoietin (EPO) Administration Schedule

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ClinicalTrials.gov Identifier: NCT01111630
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Anaemia Drug: recomon (Epoetin Beta) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
Study Start Date : October 2009
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. The hemoglobin variability between once & three times weekly administration [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. The hematocrit variability between once & three times weekly administration [ Time Frame: 24 weeks ]
  2. Mean value of Hb and Hct between once & three times weekly administration [ Time Frame: 24 weeks ]
  3. Drop out rate during dose fix period [ Time Frame: 24 weeks ]
  4. Mean value of Hb and Hct during dose fix period [ Time Frame: 24 weeks ]
  5. Variability of Hb and Hct during dose fix period [ Time Frame: 24weeks ]
  6. Weekly oetin-beta maintenance dose between once & three times weekly administration [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111630


Locations
Korea, Republic of
NHIC Ilsan Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: SugKyun Shin, Ph.D. NHIC Ilsan hospital

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01111630     History of Changes
Other Study ID Numbers: CWP_RCM_R01
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by JW Pharmaceutical:
chronic renal failure
Anaemia

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics