A Study to Evaluate the Efficacy of Converting from Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects with Chronic Kidney Disease Receiving Haemodialysis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004499-35-HU

Enrollment

200

Registered

2005-01-25

Start date

2005-03-22

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

Anemia caused by chronic kidney didease. MedDRA version: 6.1 Level: PT Classification code 10038444

Interventions

Trade Name: Aranesp Product Name: Darbepoetin Alfa 10 µg/0.4 ml Prefilled Syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin Alfa Other descriptive name: 10 µg/0.4 ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Diagnosis of CKD and receiving dialysis for at least 3 months prior to screening · = 18 years of age · Baseline Hb level = 10.0 g/dL and = 13.0 g/dL · Adequate iron stores (defined as serum ferritin >100 µg/L or transferrin saturation (TSAT) > 20%) · Stable IV (Epoetin alfa or beta) or SC rHuEPO (Epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Received SC Epoetin alpha in the 12 months before screening · Uncontrolled hypertension (diastolic blood pressure > 100 mm Hg or systolic blood pressure > 180 mmHg on 2 separate occasions during screening) · Prior history (within 12 weeks before enrolment) of cardiovascular events including: - acute myocardial ischemia - hospitalization for congestive heart failure - myocardial infarction · Pregnant or breast-feeding women. All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. · Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study. · Known sensitivity to any of the products to be administered during dosing. · Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) = 10 g/dL and = 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.;Secondary Objective: 1. To determine the proportion of subjects with a mean Hb > 11 g/dL. 2. To determine the mean change in Hb between screening/baseline and the evaluation period. 3. To assess the safety of switching subjects to IV darbepoetin alfa by measurement of adverse events and laboratory parameters.;Primary end point(s): Primary Endpoint · To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) = 10 g/dL and = 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL. Secondary Endpoints · To determine the proportion of subjects with a mean Hb > 11 g/dL. . To determine the mean change in Hb between screening/baseline and the evaluation period. . To assess the safety of switching subjects to IV darbepoetin alfa by measurement of adverse events and laboratory parameters. Safety Endpoints · Subject incidence, nature, and severity of adverse events, subject incidence of red blood cell transfusions, and laboratory parameters.	—

Measure

Time frame

Main Objective: To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) = 10 g/dL and = 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.;Secondary Objective: 1. To determine the proportion of subjects with a mean Hb > 11 g/dL. 2. To determine the mean change in Hb between screening/baseline and the evaluation period. 3. To assess the safety of switching subjects to IV darbepoetin alfa by measurement of adverse events and laboratory parameters.;Primary end point(s): Primary Endpoint · To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) = 10 g/dL and = 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL. Secondary Endpoints · To determine the proportion of subjects with a mean Hb > 11 g/dL. . To determine the mean change in Hb between screening/baseline and the evaluation period. . To assess the safety of switching subjects to IV darbepoetin alfa by measurement of adverse events and laboratory parameters. Safety Endpoints · Subject incidence, nature, and severity of adverse events, subject incidence of red blood cell transfusions, and laboratory parameters.

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Countries

Hungary

Outcome results

None listed

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