Back to resultsA Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months;
- adequate iron status;
- rapid chronic kidney disease progression.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Secondary Outcome Measures
Time to achievement of response
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Mean time spent in Hb range of 10.0 - 12.0g/dL
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00680563
Brief Title
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
Official Title
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
sc every month (starting dose 1.2 micrograms/kg)
Primary Outcome Measure Information:
Title
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Time Frame
Week 32
Secondary Outcome Measure Information:
Title
Time to achievement of response
Time Frame
Throughout study
Title
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Time Frame
Throughout study
Title
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Time Frame
Throughout study
Title
Mean time spent in Hb range of 10.0 - 12.0g/dL
Time Frame
Throughout study
Title
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
chronic renal anemia;
no ESA therapy during previous 3 months;
adequate iron status;
rapid chronic kidney disease progression.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring hospitalization in previous 6 months;
significant acute or chronic bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Buenos Aires
ZIP/Postal Code
CP2700
Country
Argentina
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
City
Blumenau
ZIP/Postal Code
89010-500
Country
Brazil
City
Botucatu
ZIP/Postal Code
18618-000
Country
Brazil
City
Curitiba
ZIP/Postal Code
80250-070
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04039-901
Country
Brazil
City
Santiago de Chile
ZIP/Postal Code
056
Country
Chile
City
Santiago
ZIP/Postal Code
8900000
Country
Chile
City
Barranquilla
ZIP/Postal Code
575
Country
Colombia
City
Cali
ZIP/Postal Code
572
Country
Colombia
City
Envigado
ZIP/Postal Code
571
Country
Colombia
City
Medellin
ZIP/Postal Code
0
Country
Colombia
City
San Jose
Country
Costa Rica
City
Quito
ZIP/Postal Code
2569
Country
Ecuador
City
Guatemala City
Country
Guatemala
City
Panama City
Country
Panama
City
Lima
ZIP/Postal Code
L13
Country
Peru
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
City
Caracas
ZIP/Postal Code
1020
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
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