- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077766
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
September 16, 2016 updated by: Hoffmann-La Roche
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa.
The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
313
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Blacktown, Australia, NSW 2148
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Brisbane, Australia, 4102
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Clayton, Australia, 3168
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Gosford, Australia, 2250
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Parkville, Australia, 3050
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Sydney, Australia, 1871
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Graz, Austria, 8036
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Aalst, Belgium, 9300
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Bruxelles, Belgium, 1070
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Bruxelles, Belgium, 1200
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Liege, Belgium, 4000
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6G 2B7
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British Columbia
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Kamloops, British Columbia, Canada, V2C 2T1
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Vancouver, British Columbia, Canada, V5Z 1M9
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V8
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Ontario
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Kitchener, Ontario, Canada, N2G 1N9
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Mississauga, Ontario, Canada, L5M 2V8
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Aalborg, Denmark, 9100
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Odense, Denmark, 5000
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Roskilde, Denmark, 4000
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HUS, Finland, 00029
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Aubervilliers, France, 93307
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Montpellier, France, 34295
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Nice, France, 06002
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Strasbourg, France, 67091
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Tarbes, France, 65013
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Toulouse, France, 31077
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Hann. Münden, Germany, 34346
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Nürnberg, Germany, 90431
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Villingen-schwenningen, Germany, 78054
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Bergamo, Italy, 24100
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Lecco, Italy, 23900
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Livorno, Italy, 57100
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Messina, Italy, 98158
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Pavia, Italy, 27100
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Badalona, Spain, 08915
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Barcelona, Spain, 08036
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Córdoba, Spain, 10004
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Madrid, Spain, 28035
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Oviedo, Spain, 33006
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Salamanca, Spain, 37008
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Santander, Spain, 39008
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Karlstad, Sweden, 65185
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Stockholm, Sweden, 18288
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Aarau, Switzerland, 5001
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Lausanne, Switzerland, 1003
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving darbepoetin alfa iv for at least 8 weeks before screening.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RO0503821 (1x/2 Weeks)
Eligible participants will be administered with RO0503821 ([methoxy polyethylene glycol-epoetin beta] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52.
The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
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RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52.
The starting dose of RO0503821 (60, 100, or 180 micro gram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
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Active Comparator: Darbepoetin (1x/1-2 Weeks)
Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.
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Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period
Time Frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
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A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately.
Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value.
All blood samples for Hb measurements were taken prior to study drug administration.
The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs.
The baseline period was defined as Week -4 to Week -1.
The evaluation period was defined as Week 29 to Week 36.
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Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration
Time Frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
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The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant.
The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed.
The evaluation period was defined as Week 29 to Week 36.
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Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
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Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods
Time Frame: Week 1 to Week 36
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A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported.
A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration.
The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).
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Week 1 to Week 36
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Number of Participants With Marked Laboratory Abnormalities
Time Frame: Up to Week 52
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A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant.
Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/liter [L]), platelets (100 - 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
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Up to Week 52
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Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Time Frame: Baseline, Week 36, and Week 52
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Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant.
Blood pressure was taken in the sitting position after at least 5 minutes rest.
An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).
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Baseline, Week 36, and Week 52
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Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
Time Frame: Baseline, Week 36, and Week 52
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Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.
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Baseline, Week 36, and Week 52
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Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths
Time Frame: Up to Week 52
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An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
Overall deaths occurred in the study were reported.
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Up to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
February 12, 2004
First Submitted That Met QC Criteria
February 13, 2004
First Posted (Estimate)
February 16, 2004
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
September 16, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA17283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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