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

• Conditions: Anemia caused by chronic kidney didease.; MedDRA version: 6.1Level: PTClassification code 10038444

• Registration Number: EUCTR2004-004499-35-HU
• Lead Sponsor: Amgen Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 < 25% change in weekly dose and no change in frequency or route)
· Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).

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

· 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified