- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077610
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
November 23, 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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin.
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)
673
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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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
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London, Ontario, Canada, N6A 5A5
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Mississauga, Ontario, Canada, L5M 2V8
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Scarborough, Ontario, Canada, M1H 3G4
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Toronto, Ontario, Canada, M5G 2C4
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Toronto, Ontario, Canada, M9N 1N8
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 1N4
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Aubervilliers, France, 93307
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Bordeaux, France, 33076
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La Tronche, France, 38700
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Paris, France, 75 016
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Paris, France, 75651
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Paris, France, 75015
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Toulouse, France, 31059
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Dortmund, Germany, 44263
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Ellwangen, Germany, 73479
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München, Germany, 80804
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Nürnberg, Germany, 90431
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Stuttgart, Germany, 70191
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Wiesbaden, Germany, 65191
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Wiesloch, Germany, 69168
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Como, Italy, 22100
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Lecco, Italy, 23900
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Lodi, Italy, 26900
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Milano, Italy, 20162
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Pavia, Italy, 27100
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Bergen, Norway, 5021
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Levanger, Norway, 7600
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Lillehammer, Norway, 2629
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Trondheim, Norway, 7006
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Barcelona, Spain, 08003
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La Coruna, Spain, 15006
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Madrid, Spain, 28007
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Malaga, Spain, 29010
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Sevilla, Spain, 41013
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Lausanne, Switzerland, 1011
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Lausanne, Switzerland, 1003
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Alabama
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Birmingham, Alabama, United States, 35211
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Mobile, Alabama, United States, 36608
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Montgomery, Alabama, United States, 36106
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California
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Encino, California, United States, 91356
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Irvine, California, United States, 92868
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Los Angeles, California, United States, 90095
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Monterey Park, California, United States, 91754
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Riverside, California, United States, 92501
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Sacramento, California, United States, 95816-5119
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San Diego, California, United States, 92120
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San Diego, California, United States, 92103-8342
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San Francisco, California, United States, 94117
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San Jose, California, United States, 95116-1906
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Colorado
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Colorado Springs, Colorado, United States, 80909
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Denver, Colorado, United States, 80262
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Lakewood, Colorado, United States, 80260
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Florida
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Ocala, Florida, United States, 34471
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Pembroke Pines, Florida, United States, 33028
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Georgia
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Atlanta, Georgia, United States, 30342
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Augusta, Georgia, United States, 30901
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Illinois
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Chicago, Illinois, United States, 60612
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Maywood, Illinois, United States, 60153
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Kentucky
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Louisville, Kentucky, United States, 40202-1718
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Louisiana
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Covington, Louisiana, United States, 70433
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Massachusetts
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Boston, Massachusetts, United States, 02215
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Boston, Massachusetts, United States, 02115
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Springfield, Massachusetts, United States, 01107
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Michigan
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Detroit, Michigan, United States, 48202-2689
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Minnesota
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Brooklyn Center, Minnesota, United States, 55430
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New Jersey
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Paterson, New Jersey, United States, 07503
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New Mexico
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Albuquerque, New Mexico, United States, 87131
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New York
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Bronx, New York, United States, 10467
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Brooklyn, New York, United States, 11203
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Great Neck, New York, United States, 11021
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Mineola, New York, United States, 11501
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New York, New York, United States, 10021
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New York, New York, United States, 10128
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Stony Brook, New York, United States, 11794-8161
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7155
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Raleigh, North Carolina, United States, 27609
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Winston-salem, North Carolina, United States, 27157-1023
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Ohio
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Cincinnati, Ohio, United States, 45267-0585
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Toledo, Ohio, United States, 43606
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Oregon
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Portland, Oregon, United States, 97210
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Pennsylvania
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Erie, Pennsylvania, United States, 16502
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15261
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Pittsburgh, Pennsylvania, United States, 15224
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South Carolina
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Orangeburg, South Carolina, United States, 29118
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Nashville, Tennessee, United States, 37232
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Nashville, Tennessee, United States, 37205
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Texas
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Austin, Texas, United States, 78705
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Houston, Texas, United States, 77054
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Houston, Texas, United States, 77099
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San Antonio, Texas, United States, 78229
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Vermont
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Burlington, Vermont, United States, 05401
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Virginia
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Fairfax, Virginia, United States, 22031
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Richmond, Virginia, United States, 23298
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
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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 IV epoetin 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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: RO0503821 (1x/2 Weeks)
Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks.
Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
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60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
Other Names:
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EXPERIMENTAL: RO0503821 (1x/4 Weeks)
Participants received RO0503821 once every four weeks intravenously for 52 weeks.
Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
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120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Other Names:
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ACTIVE_COMPARATOR: Epoetin (1-3x/Weeks)
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
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intravenously 3 times weekly for 52 weeks, as prescribed
Other Names:
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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 (Hb) Concentration From Baseline to Evaluation Period
Time Frame: Baseline, Week 29 to Week 36
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A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately.
Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb.
At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
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Baseline, 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 Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
Time Frame: Baseline, Week 29 to Week 36
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The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant.
The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.
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Baseline, Week 29 to Week 36
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The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Time Frame: Week 1 to Week 36
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The number of participants who received RBC transfusions during the titration and evaluation periods were reported .
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Week 1 to Week 36
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Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
Time Frame: Up to Week 53
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Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range.
These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively.
The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.
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Up to Week 53
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Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
Time Frame: Up to Week 53
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Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range.
These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively.
The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10
(millimol/litre [mmol/L]); potassium 2.90-5.80
mmol/L, and phosphorus 0.75-1.60
mmol/L
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Up to Week 53
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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 was measured by manual assessment or automated reading throughout the entire 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 (SBP) and diastolic (DBP) 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 value and a value for specified time period.
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Baseline, Week 36 and Week 52
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Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
Time Frame: Upto Week 53
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An 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.
An 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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Upto Week 53
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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
February 1, 2004
Primary Completion (ACTUAL)
August 1, 2005
Study Completion (ACTUAL)
August 1, 2005
Study Registration Dates
First Submitted
February 10, 2004
First Submitted That Met QC Criteria
February 12, 2004
First Posted (ESTIMATE)
February 13, 2004
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2017
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA16739
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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