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

A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA

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

Study Overview

• Status: Unknown
• Conditions: PD
• Intervention / Treatment: Drug: Mircera

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

• Study Type: Interventional
• Enrollment (Anticipated): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Dae Joon g Kim
    • Principal Investigator: Dae Joong Kim
  • Seoul, Korea, Republic of, 135-710
    • Not yet recruiting
    • Samsung Medical Center
    • Contact: Dae Joong Kim
    • Principal Investigator: Dae Joong Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mircera Arm; Once Monthly Mircera	Drug: Mircera; Once Monthly Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with hemoglobin 10~12 g/dl	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	Visit 0 ~ visit 10 (10 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin stability, Dose adjustment	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	Visit0~Visit 10 (10 Months)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Dae Joong Kim, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: PD; Mircera; Maitenance
• Other Study ID Numbers: SMC 2011-10-131