A Multicenter, 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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000074-79-AT

Enrollment

100

Registered

2006-02-17

Start date

2006-05-19

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis MedDRA version: 7.0 Level: PT Classification code 10049105

Interventions

Product Name: Darbepoetin alpha 10 microgram solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin alpha Concentration unit: µg microgram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: = 18 years of age Receiving dialysis for = 3 months before enrollment The mean of 2 screening Hb values taken at least 7 days apart must be = 11.0 g/dL and = 13.0 g/dL The 2 screening Hb values must be = 11 g/dL and = 13 g/dL Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment (defined as = 25% change in dose over the 6-week period immediately prior to enrollment and no change in frequency) Adequate iron stores (serum ferritin > 100 µg/L) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Uncontrolled hypertension Prior history (within 12 weeks before enrollment) of events including: acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack Other hematological disorders Upper or lower GI bleeding within the prior 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the proportion of subjects successfully achieving a mean Hemoglobin (Hb) = 11 g/dL during the evaluation period following extension from QW to Q2W darbepoetin alfa administration.;Secondary Objective: To determine Hb values over the duration of the study To determine darbepoetin alfa doses over the duration of the study To assess the safety of darbepoetin alfa administered Q2W ;Primary end point(s): Achievement of a mean Hb during the evaluation period > 11 g/dL.	—

Measure

Time frame

Main Objective: To assess the proportion of subjects successfully achieving a mean Hemoglobin (Hb) = 11 g/dL during the evaluation period following extension from QW to Q2W darbepoetin alfa administration.;Secondary Objective: To determine Hb values over the duration of the study To determine darbepoetin alfa doses over the duration of the study To assess the safety of darbepoetin alfa administered Q2W ;Primary end point(s): Achievement of a mean Hb during the evaluation period > 11 g/dL.

—

Countries

Austria, Germany, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026