Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

NCT00116701 | Completed Phase 3

• 1 other identifier: 20040218
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Kidney Disease

Keywords

Chronic Kidney Disease (CKD); Haemoglobin (Hb); Erthropoetin (EPO); End Stage Renal Disease (ESRD); Recombinant Human Erthropoetic (rHuEPO); Anaemia; Darbepoetin Alfa, Aranesp®; Haemodialysis; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)

• Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)

Secondary Outcomes (7)

• Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2

• 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

• Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2

• Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period

• Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period

Interventions

Aranesp® DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 1, 2005
• Study Start: May 1, 2005
• Last Updated: May 5, 2008

Record last verified: 2008-05