Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00436995
First received: February 15, 2007
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.


Condition Intervention Phase
Chronic Kidney Disease
Drug: Darbepoetin Alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Q2W doses over duration of study. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • Hb values during the evaluation period. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • adverse events during study [ Time Frame: 33 weeks ] [ Designated as safety issue: Yes ]
  • Hb Rate of Rise during study and excursions above 14g/dL [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Drug: Darbepoetin Alfa
Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving dialysis for 3 months or more before enrollment.
  • The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
  • Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
  • Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion Criteria:

  • Uncontrolled hypertension
  • Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
  • Other hematological disorders
  • Upper or lower GI bleed within the prior 6 months
  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: NCT00436995

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00436995     History of Changes
Other Study ID Numbers: 20050210
Study First Received: February 15, 2007
Last Updated: January 20, 2011
Health Authority: Austria: Secretariat of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health

Keywords provided by Amgen:
Dialysis
Anaemia

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

ClinicalTrials.gov processed this record on September 30, 2014