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

NCT01807481 | Unknown Phase 4

• 1 other identifier: SMC 2011-10-131
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

PD

Keywords

Mircera; PD; Maitenance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemoglobin stability, Dose adjustment

  Visit0~Visit 10 (10 Months)

Study Arms (1)

Mircera Arm

EXPERIMENTAL

Once Monthly Mircera

Drug: Mircera

Interventions

Mircera DRUG

Once Monthly Mircera

Mircera Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 135-710, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

continuous erythropoietin receptor activator

Study Officials

• Dae Joong Kim

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Joong Kim

CONTACT

82234103441; daejoong.smc.kim@samsung.com

Dae Joong Kim

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

KR (2)