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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01807481
• Other study ID #: SMC 2011-10-131
• Status: Recruiting
• Phase: Phase 4
• First received: March 6, 2013
• Last updated: June 11, 2013
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: June 2013
• Source: Samsung Medical Center
• Contact: Dae Joong Kim
• Phone: 82234103441
• Email: daejoong.smc.kim[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 101
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• PD

Intervention

Drug:
• Mircera
Once Monthly Mircera

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes