Study of Erythropoietin (EPO) Administration Schedule

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111630
• Other study ID #: CWP_RCM_R01
• 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

Related Conditions & MeSH terms

• Anaemia
• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

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