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A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

NCT ID: NCT00440063

Last Updated: 2007-12-20

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

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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epoetin beta [NeoRecormon]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-80 years of age;
* stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
* Hb \<100g/L, TSAT\>=20%, and ferritin \>=100 mcg/L at screening.

Exclusion Criteria

* anticipating to go on renal replacement therapy;
* anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
* uncontrolled hypertension;
* congestive heart failure;
* active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Adelaide, , Australia

Site Status

Gosford, , Australia

Site Status

Herston, , Australia

Site Status

Liverpool, , Australia

Site Status

Parkville, , Australia

Site Status

Perth, , Australia

Site Status

Sydney, , Australia

Site Status

Tasmania, , Australia

Site Status

Woolloongabba, , Australia

Site Status

Countries

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Australia

Other Identifiers

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ML20828

Identifier Type: -

Identifier Source: org_study_id