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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01111630
Other study ID # CWP_RCM_R01
Secondary ID
Status Completed
Phase Phase 4
First received April 25, 2010
Last updated May 12, 2014
Start date October 2009
Est. completion date January 2014

Study information

Verified date May 2014
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
recomon (Epoetin Beta)
administer once weekly
recomon (Epoetin Beta)
administer three times weekly

Locations

Country Name City State
Korea, Republic of NHIC Ilsan Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The hemoglobin variability between once & three times weekly administration 24 weeks No
Secondary The hematocrit variability between once & three times weekly administration 24 weeks No
Secondary Mean value of Hb and Hct between once & three times weekly administration 24 weeks No
Secondary Drop out rate during dose fix period 24 weeks No
Secondary Mean value of Hb and Hct during dose fix period 24 weeks No
Secondary Variability of Hb and Hct during dose fix period 24weeks No
Secondary Weekly oetin-beta maintenance dose between once & three times weekly administration 24 weeks No
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