Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD

Phase 4

• Conditions: PD
• Interventions: Drug: Mircera

• Registration Number: NCT01807481
• Lead Sponsor: Samsung Medical Center

Brief Summary

The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 \~ 12.0 g/dl during the evaluation period

Detailed Description

The secondary objective of study is

* No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb

* Incidence of RBC transfusion during the titration and evaluation periods

* Mean Hb during the total study period

* Intrapatient Hb variability (mean within-patient standard deviation for Hb)

* Frequency of Micera dose level

* safety

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12
• Primary Completion: 2015-02
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mircera Arm	Mircera	Once Monthly Mircera

Primary Outcome Measures

Name	Time	Method
Number of patients with hemoglobin 10~12 g/dl	Visit 0 ~ visit 10 (10 months)	The primary objective of this study is to evaluate the no of patients which maintain the Hb-level between 10.0\~13.0 g/dL during the evaluation period

Secondary Outcome Measures

Name	Time	Method
Hemoglobin stability, Dose adjustment	Visit0~Visit 10 (10 Months)	Incidence of RBC transfusion during the titration and evaluation periods Mean Hb during the total study period Intrapatient Hb variability (mean within patient standard deviations for Hb) Comparison between baseline and evaluation period mean Hb level Frequency of dose adjustments Safety

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of