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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00436995

Enrollment

114

Registered

2007-02-19

Start date

2006-04-30

Completion date

2008-12-31

Last updated

2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Dialysis, Anaemia

Brief 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.

Interventions

DRUGDarbepoetin 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.	33 weeks

Secondary

Measure	Time frame
Q2W doses over duration of study.	33 weeks
Hb values during the evaluation period.	33 weeks
adverse events during study	33 weeks
Hb Rate of Rise during study and excursions above 14g/dL	33 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026