Phase IV Study to Evaluate the Efficacy and Safety of Mir... | NCT01807481

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

NCT01807481

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jun 12, 2013Estimated

Enrollment

101Estimated

Phase

Phase 4

Conditions

Interventions

Mircera

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Feb 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Estimated

Label	Type	Description	Intervention Names
Mircera Arm	Experimental	Once Monthly Mircera	Drug: Mircera

Name	Type	Description	Arm Group Labels	Other Names
Mircera	Drug	Once Monthly Mircera	Mircera Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Dae Joong Kim	Contact	82234103441		daejoong.smc.kim@samsung.com
Dae Joong Kim	Contact