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A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

NCT ID: NCT00922610

Last Updated: 2016-11-02

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

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-07-31

Brief Summary

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This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks

Interventions

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methoxy polyethylene glycol-epoetin beta [Mircera]

sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* chronic kidney disease;
* anemia (Hb \>8 and \<11 g/dL);
* regular dialysis or predialysis, not treated with ESA.

Exclusion Criteria

* transfusion of red blood cells during previous 8 weeks;
* poorly controlled hypertension;
* overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
* active malignant disease (except melanoma of skin).
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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Cavite, , Philippines

Site Status

Makati City, , Philippines

Site Status

Manila, , Philippines

Site Status

Marikina City, , Philippines

Site Status

Pasig, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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ML21983

Identifier Type: -

Identifier Source: org_study_id