A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

Brief Summary

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This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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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

Study Groups

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Correction Phase: CERA

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]

Intervention Type DRUG

0.6 micrograms/kg every 2 weeks

Correction Phase: Epoetin Beta

Group Type ACTIVE_COMPARATOR

Epoetin

Intervention Type DRUG

As prescribed, iv, 3 times weekly

Interventions

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methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]

0.6 micrograms/kg every 2 weeks

Intervention Type DRUG

Epoetin

As prescribed, iv, 3 times weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* chronic renal anemia;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.

Exclusion Criteria

* previous therapy with epoetin within 8 weeks prior to screening;
* overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
* RBC transfusions within 8 weeks before screening or during screening period;
* active malignant disease except non-melanoma skin cancer.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No