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

Chronic Kidney Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436995
• Other study ID #: 20050210
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2007
• Last updated: January 20, 2011
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Secretariat of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.		33 weeks	No
Secondary	Q2W doses over duration of study.		33 weeks	No
Secondary	Hb values during the evaluation period.		33 weeks	No
Secondary	adverse events during study		33 weeks	Yes
Secondary	Hb Rate of Rise during study and excursions above 14g/dL		33 weeks	No

External Links

•   AmgenTrials clinical trials website