This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: December 20, 2007
Last verified: December 2007
The purpose of this study is to compare once a week and once every other week darbepoetin alfa on the change in hemoglobin levels between the screening/baseline period and the evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing requirements and red blood cell transfusions.

Condition Intervention Phase
Anemia Drug: darbepoetin alfa Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Comparative Study of Darbepoetin Alfa Given Once Weekly or Once Every Other Week for Treatment of Anemia in Hemodialysis Subjects

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Comparison between once a week and once every other week darbepoetin alfa on the change in Hb level between the screening/baseline period and the evaluation period (weeks 25-30)

Secondary Outcome Measures:
  • Instability of Hb concentration during the evaluation period
  • Weekly dose and frequency of darbepoetin alfa during the evaluation period
  • RBC transfusions during the evaluation period.

Study Start Date: August 2002
Estimated Study Completion Date: September 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - -Receiving hemodialysis for at least 6 months before screening - -Clinically stable as judged by the investigator - Stable IV rHuEPO therapy administered 1, 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than or equal to 25% change [up or down] in weekly dose and no change in frequency over 8 weeks) - Adequate iron stores (serum ferritin greater than or equal to 100μg/L) during the screening period - Available for follow up assessments - Before any study specific procedure is carried out, the subject, or his/her legally acceptable representative must give informed consent for participation in the study Exclusion Criteria: - -Treatment for grand mal epilepsy in the last 6 months - Congestive heart failure (New York Heart Association [NYHA] class III or IV)- - Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement greater than or equal to 110mmHg during the screening period - Clinical evidence of current uncontrolled hyperparathyroidism (e.g., serum parathyroid hormone greater than 1500pg/mL) within the past 12 months - Major surgery within 3 months before screening (excludes vascular access surgery) - Previously diagnosed HIV or chronic hepatitis B infection - Clinical evidence of current malignancy excluding basal cell or squamous cell carcinoma of the skin - Systemic hematological disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia - Alanine transaminase (ALT) and aspartate transaminase (AST) greater than 2 times the upper limit of the normal range - RBC transfusion(s) within 12 weeks before screening or during the screening/baseline period, or active bleeding - Clinical evidence of current systemic infections - Androgen therapy within 12 weeks before screening - No prior treatment with darbepoetin alfa - Currently enrolled in, or has not yet completed a period of at least 30 days since ending, other investigational device or drug trial(s). Subjects receiving other investigational agent(s) may only enter the study after discussion and agreement with Amgen - Pregnancy (women of child-bearing potential must be using adequate contraception) - Breast feeding - Psychiatric, addictive, or other disorder that compromises ability to give truly informed consent or is likely to alter compliance - Anticipating or scheduled for a living-related kidney transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00119587

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00119587     History of Changes
Other Study ID Numbers: 20010219
Study First Received: June 30, 2005
Last Updated: December 20, 2007

Keywords provided by Amgen:
darbepoetin alfa
Clinical Trial

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa
Hematinics processed this record on August 18, 2017