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

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-24
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

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

Inclusion Criteria

Treatment Period 1:

1. Diagnosis of CKD and receiving dialysis for at least 3 months prior to screening
2. = 18 years of age
3. Baseline Hb level = 10.0 g/dL and = 13.0 g/dL
4. Adequate iron stores (defined as serum ferritin =100 µg/L or transferrin saturation (TSAT) = 20%)
5. Stable IV (Epoetin alfa or beta) or SC rHuEPO (Epoetin beta) therapy 1, 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)
6. Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).

Treatment Period 2:

1. Completed Treatment Period 1.
2. Hb > 11.0 g/dL and = 13.0 g/dL at week 24
3. Stable QW dose of IV darbepoetin alfa during Evaluation Period 1 (weeks 21 to 24). A stable dose is defined as:
a. no prescribed dose increases, prescribed dose reductions or withheld doses
b. no more than 1 missed dose
c. no changes to dose frequency or route of administration
4. Before any protocol specific procedure for Treatment Period 2 is performed, the appropriate written informed consent must be obtained (see Section 12.1)
5. Adequate iron stores (defined as serum ferritin = 100 µg/L or TSAT = 20%) at week 24
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

Treatment Period 1:

1. Received SC Epoetin alpha in the 12 months before screening
2. Uncontrolled hypertension (diastolic blood pressure > 100 mm Hg)
3. 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.

Treatment Period 2:

1. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg or systolic blood pressure > 180 mmHg) on 2 separate occasions during Evaluation Period 1 (weeks 21 to 24)
2. Received a red blood cell transfusion during study weeks 16 to 24

Study & Design

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