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
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
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014