NCT01807481

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• PD

Interventions

Type	Name	Description
DRUG	Mircera	Once Monthly Mircera

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2013-03-08
• Last updated: 2013-06-12

Locations

2 sites across 1 country: South Korea