Study Stopped
Strategic decision unrelated to safety or efficacy
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease
1 other identifier
interventional
39
4 countries
22
Brief Summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2008
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2007
CompletedFirst Posted
Study publicly available on registry
April 19, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
April 1, 2016
CompletedApril 1, 2016
March 1, 2016
3.2 years
April 18, 2007
March 2, 2016
March 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
Secondary Outcomes (4)
Time to Achievement of Response
Baseline to Week 40
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
EEP (Weeks 29 to 36)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
EEP (Weeks 29 to 36)
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
EEP (Weeks 29 to 36)
Study Arms (1)
Methoxy Polyethylene Glycol-epoetin Beta
EXPERIMENTALMethoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Interventions
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Eligibility Criteria
You may qualify if:
- chronic kidney disease, stage 3 or 4;
- anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]).
You may not qualify if:
- previous therapy with ESA within 12 weeks prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- red blood cell transfusions within 8 weeks before screening;
- active malignant disease (except non-melanoma skin cancer).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Tallinn, 10617, Estonia
Unknown Facility
Tallinn, 13419, Estonia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
HUS, 00029, Finland
Unknown Facility
Joensuu, 80210, Finland
Unknown Facility
Jyväskylä, 40620, Finland
Unknown Facility
Kajaani, 87140, Finland
Unknown Facility
Kotka, 48210, Finland
Unknown Facility
Porvoo, 06151, Finland
Unknown Facility
Tampere, 33521, Finland
Unknown Facility
Turku, 20521, Finland
Unknown Facility
Jūrmala, LV2015, Latvia
Unknown Facility
Liepāja, 3402, Latvia
Unknown Facility
Riga, 1002, Latvia
Unknown Facility
Riga, LV1038, Latvia
Unknown Facility
Valmiera, 4201, Latvia
Unknown Facility
Ventspils, LV 3601, Latvia
Unknown Facility
Hønefoss, 3504, Norway
Unknown Facility
Lillehammer, 2629, Norway
Unknown Facility
Oslo, 0407, Norway
Unknown Facility
Stavanger, 4011, Norway
Unknown Facility
Trondheim, 7006, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early due to strategic decision unrelated to safety or efficacy.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2007
First Posted
April 19, 2007
Study Start
February 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
April 1, 2016
Results First Posted
April 1, 2016
Record last verified: 2016-03