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

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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PD

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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Mircera Arm

Once Monthly Mircera

Group Type EXPERIMENTAL

Mircera

Intervention Type DRUG

Once Monthly Mircera

Interventions

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Mircera

Once Monthly Mircera

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.≥18 yr of age
* 2.peritoneal dialysis for ≥12wk before screening and during baseline period
* 3.weekly Kt/V ≥1.8 for PD patients
* 4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
* 5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
* 6.continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period
* 7.adequate iron status defined as serum ferritin ≥ 100ng/ml or transferrin saturation≥20%(mean of two values deteremined in month -2 and -1)

Exclusion Criteria

* 1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
* 2.RBC transfusions within 2 months before screening or during baseline period
* 3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
* 4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
* 5.C-reactive protein\>30mg/dl
* 6.poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening
* 7.platelets \> 500X109/L
* 8.pure red cell aplasia
* 9.chronic congestive heart failure(New Yorj Heart Association class IV)
* 10.Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline
* 11.Life expectancy \< 12months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No