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A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

NCT ID: NCT01156363

Last Updated: 2015-12-03

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

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-01-31

Brief Summary

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This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.

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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Single Arm

Group Type EXPERIMENTAL

Dialysis

Intervention Type PROCEDURE

regular haemodialysis or peritoneal dialysis

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

once monthly, subcutaneously or intravenously, for 32 weeks

Interventions

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Dialysis

regular haemodialysis or peritoneal dialysis

Intervention Type PROCEDURE

methoxy polyethylene glycol-epoetin beta [Mircera]

once monthly, subcutaneously or intravenously, for 32 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/=18 years of age
* chronic renal anaemia
* haemoglobin 10.0-12.0g/dl at screening
* adequate iron status
* continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months
* regular haemodialysis or regular peritoneal dialysis for \>/= 3 months

Exclusion Criteria

* uncontrolled hypertension
* haemoglobinopathy
* anaemia due to haemolysis
* pure red cell aplasia (PRCA)
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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Kaohsiung City, , Taiwan

Site Status

New Taiepei City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML22299

Identifier Type: -

Identifier Source: org_study_id