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

PD Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PD

• NCT number: NCT01807481
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Dae Joong Kim
• Phone: 82234103441
• Email: daejoong.smc.kim@samsung.com
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2013
• Completion date: August 2015