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

This study is ongoing, but not recruiting participants.

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00436995

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 III

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

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.

Secondary Outcome Measures:

Q2W doses over duration of study.
Hb Rate of Rise during study and excursions above 14g/dL
Hb concerntrations during the evaluation period.

Estimated Enrollment:	100
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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
Adeqaute iron stores (serun ferritin equaqlt to or greater than 100 ug/L

Exclusion Criteria:

Untrolled 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:

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050210
Study First Received:	February 15, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00436995
Health Authority:	Austria: Secretariat of Health; Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency

Keywords provided by Amgen:

Dialysis
Aneamia

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009