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A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

NCT ID: NCT00576628

Last Updated: 2016-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

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This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C.E.R.A

Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Intervention Type DRUG

Recommended starting dose 1.2 micrograms/kg sc monthly

Interventions

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methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Recommended starting dose 1.2 micrograms/kg sc monthly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* chronic renal anemia, with no need for dialysis expected in next 3 months;
* adequate iron status.

Exclusion Criteria

* previous epoetin therapy within 12 weeks prior to treatment;
* transfusion of red blood cells during 2 months prior to screening;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B 12 deficiency.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Irkutsk, , Russia

Site Status

Khanty-Mansiysk, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Nizhny Novgorod, , Russia

Site Status

Omsk, , Russia

Site Status

Orenburg, , Russia

Site Status

Rostov-on-Don, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saratov, , Russia

Site Status

Tyumen, , Russia

Site Status

Ufa, , Russia

Site Status

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ML20978

Identifier Type: -

Identifier Source: org_study_id