Back to resultsA Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Philippines
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 kidney disease;
- anemia (Hb >8 and <11 g/dL);
- regular dialysis or predialysis, not treated with ESA.
Exclusion Criteria:
- transfusion of red blood cells during previous 8 weeks;
- poorly controlled hypertension;
- overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
- active malignant disease (except melanoma of skin).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients
Secondary Outcome Measures
>=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922610
Brief Title
A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
Official Title
An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 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 study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is <100 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (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 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks
Primary Outcome Measure Information:
Title
Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients
Time Frame
24 weeks after first dose, through week 25
Secondary Outcome Measure Information:
Title
>=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments
Time Frame
At end of 24 weeks treatment
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 kidney disease;
anemia (Hb >8 and <11 g/dL);
regular dialysis or predialysis, not treated with ESA.
Exclusion Criteria:
transfusion of red blood cells during previous 8 weeks;
poorly controlled hypertension;
overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
active malignant disease (except melanoma of skin).
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
Cavite
ZIP/Postal Code
4103
Country
Philippines
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Marikina
ZIP/Postal Code
1805
Country
Philippines
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
12. IPD Sharing Statement
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A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
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