Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Disease

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aranesp®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Czechia Hungary

Other Identifiers

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20040218

Identifier Type: -

Identifier Source: org_study_id