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Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146224
First Posted: September 7, 2005
Last Update Posted: February 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis

Condition Intervention Phase
Nephrology Drug: Epoetin alfa RB Drug: Epoetin alfa DT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Ratio of weekly dose at the evaluation period to the weekly dose at baseline [ Time Frame: Entire Study ]
  • Change in Heloglobin level between the screening period and the evaluation period [ Time Frame: Entire Study ]

Secondary Outcome Measures:
  • Change from baseline Hb at each measurement timepoint [ Time Frame: Entire Study ]
  • Maintaining Hemoglobin within range at each measurement timepoint [ Time Frame: Entire Study ]
  • Average Epoetin alfa dose over evaluation period [ Time Frame: evaluation period (weeks 21 - 28) ]
  • Change from baseline dose at each measurement timepoint [ Time Frame: entire study ]
  • Epoetin alfa seroreactivity [ Time Frame: entire study ]
  • Subject incidence, nature and severity of adverse events [ Time Frame: entire study ]
  • Hemoglobin variability [ Time Frame: entire study ]
  • changes from baseline laboraotry and vital sign parameters [ Time Frame: entire study ]

Estimated Enrollment: 420
Study Start Date: September 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epoetin alfa RB Drug: Epoetin alfa RB
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Experimental: Epoetin alfa DT Drug: Epoetin alfa DT
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146224


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00146224     History of Changes
Other Study ID Numbers: 20050113
First Submitted: September 6, 2005
First Posted: September 7, 2005
Last Update Posted: February 26, 2010
Last Verified: February 2010

Keywords provided by Amgen:
anemia
chronic kidney disease, CKD
hemodialysis
epoetin
Epogen®

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics