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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00146224
First received: September 6, 2005
Last updated: February 25, 2010
Last verified: February 2010
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Change in Heloglobin level between the screening period and the evaluation period [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Hb at each measurement timepoint [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Maintaining Hemoglobin within range at each measurement timepoint [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Average Epoetin alfa dose over evaluation period [ Time Frame: evaluation period (weeks 21 - 28) ] [ Designated as safety issue: No ]
  • Change from baseline dose at each measurement timepoint [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Epoetin alfa seroreactivity [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
  • Subject incidence, nature and severity of adverse events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
  • Hemoglobin variability [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
  • changes from baseline laboraotry and vital sign parameters [ Time Frame: entire study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: September 6, 2005
Last Updated: February 25, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014