Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116701
• Other study ID #: 20040218
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: May 1, 2008
• Start date: May 2005

Study information

• Verified date: May 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

Treatment period 1: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.

Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 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 less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 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 - 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aranesp®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
Primary	Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
Secondary	Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
Secondary	Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
Secondary	Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
Secondary	Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
Secondary	Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
Secondary	Treatment period 1: Change in Hb between screening/baseline and the evaluation period
Secondary	Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling