A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients
1 other identifier
interventional
28
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 2, 2016
November 1, 2016
1.4 years
June 16, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
24 weeks after first dose, through week 25
Secondary Outcomes (1)
>=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
At end of 24 weeks treatment
Study Arms (1)
1
EXPERIMENTALInterventions
sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- chronic kidney disease;
- anemia (Hb \>8 and \<11 g/dL);
- regular dialysis or predialysis, not treated with ESA.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Cavite, 4103, Philippines
Unknown Facility
Makati City, 1229, Philippines
Unknown Facility
Manila, 1000, Philippines
Unknown Facility
Marikina City, 1805, Philippines
Unknown Facility
Pasig, 1605, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
February 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11