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Study of Erythropoietin (EPO) Administration Schedule

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01111630
First received: April 25, 2010
Last updated: October 4, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Renal Failure
Anaemia
 Drug: recomon (Epoetin Beta)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • The hemoglobin variability between once & three times weekly administration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The hematocrit variability between once & three times weekly administration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean value of Hb and Hct between once & three times weekly administration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Drop out rate during dose fix period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean value of Hb and Hct during dose fix period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Variability of Hb and Hct during dose fix period [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
  • Weekly oetin-beta maintenance dose between once & three times weekly administration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: once weekly Drug: recomon (Epoetin Beta)
administer once weekly
Active Comparator: three times weekly Drug: recomon (Epoetin Beta)
administer three times weekly

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01111630     History of Changes
Other Study ID Numbers: CWP_RCM_R01
Study First Received: April 25, 2010
Last Updated: October 4, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by JW Pharmaceutical:
chronic renal failure
Anaemia

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
 Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013