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Completed

NCT Number: NCT01111630

Study of Erythropoietin (EPO) Administration Schedule

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.

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Key information

Conditions

Chronic Renal Failure Anaemia Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NHIC Ilsan Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

recomon (Epoetin Beta)

Drug

administer once weekly

Primary outcomes

  1. The hemoglobin variability between once & three times weekly administration

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Apr 27, 2010
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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