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A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077766
Recruitment Status : Completed
First Posted : February 16, 2004
Results First Posted : September 14, 2016
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Darbepoetin alfa Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arm Intervention/treatment
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).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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).

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.
Drug: Darbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.

Primary Outcome Measures :
  1. 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) ]
    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.

Secondary Outcome Measures :
  1. 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) ]
    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.

  2. Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods [ Time Frame: Week 1 to Week 36 ]
    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).

  3. Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 52 ]
    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).

  4. Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 [ Time Frame: Baseline, Week 36, and Week 52 ]
    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).

  5. Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 [ Time Frame: Baseline, Week 36, and Week 52 ]
    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.

  6. Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths [ Time Frame: Up to Week 52 ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077766

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Blacktown, Australia, NSW 2148
Brisbane, Australia, 4102
Clayton, Australia, 3168
Gosford, Australia, 2250
Parkville, Australia, 3050
Sydney, Australia, 1871
Graz, Austria, 8036
Aalst, Belgium, 9300
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1200
Liege, Belgium, 4000
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Kamloops, British Columbia, Canada, V2C 2T1
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Kitchener, Ontario, Canada, N2G 1N9
Mississauga, Ontario, Canada, L5M 2V8
Aalborg, Denmark, 9100
Odense, Denmark, 5000
Roskilde, Denmark, 4000
HUS, Finland, 00029
Aubervilliers, France, 93307
Montpellier, France, 34295
Nice, France, 06002
Strasbourg, France, 67091
Tarbes, France, 65013
Toulouse, France, 31077
Hann. Münden, Germany, 34346
Nürnberg, Germany, 90431
Villingen-schwenningen, Germany, 78054
Bergamo, Italy, 24100
Lecco, Italy, 23900
Livorno, Italy, 57100
Messina, Italy, 98158
Pavia, Italy, 27100
Badalona, Spain, 08915
Barcelona, Spain, 08036
Córdoba, Spain, 10004
Madrid, Spain, 28035
Oviedo, Spain, 33006
Salamanca, Spain, 37008
Santander, Spain, 39008
Karlstad, Sweden, 65185
Stockholm, Sweden, 18288
Aarau, Switzerland, 5001
Lausanne, Switzerland, 1003
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT00077766    
Other Study ID Numbers: BA17283
First Posted: February 16, 2004    Key Record Dates
Results First Posted: September 14, 2016
Last Update Posted: October 26, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Hematologic Diseases
Darbepoetin alfa