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A Study of Mircera for the Maintenance 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: NCT00394953
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, 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 : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Study Start Date : December 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arm Intervention/treatment
Experimental: MIRCERA
Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, starting dose

Active Comparator: Darbepoetin Alfa
Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Drug: Darbepoetin alfa
As prescribed, iv.
Other Name: Aranesp

Primary Outcome Measures :
  1. Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period [ Time Frame: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53) ]
    Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.

Secondary Outcome Measures :
  1. Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time [ Time Frame: Week 27 to Month 12 ]
    All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.

  2. Number of Participants With Marked Laboratory Abnormality Over Time [ Time Frame: Up to Week 53 ]
    Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.

  3. Median Blood Pressure Over Time [ Time Frame: Baseline (Week -4 to Week -1), Week 28, and Week 52 ]
    Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.

  4. Mean Pulse Rate Over Time [ Time Frame: Baseline (Week -4 to Week -1), Week 28, and Week 52 ]
    Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.

  5. Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths [ Time Frame: From screening to Week 56 ]
    An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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;
  • hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
  • receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

  • overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
  • transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
  • active malignancy;

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): NCT00394953

Hide Hide 88 study locations
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Adelaide, Australia, SA 5000
Clayton, Australia, 3186
Gosford, Australia, 2250
Parkville, Australia, 3052
Woolloongabba, Australia, 4102
Linz, Austria, 4010
Wien, Austria, 1090
Wien, Austria, 1220
Aalst, Belgium, 9300
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1200
Roeselare, Belgium, 8800
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Kitchener, Ontario, Canada, N2G 1N9
Mississauga, Ontario, Canada, L5M 2V8
Ottawa, Ontario, Canada, K1H 7W9
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Trois-rivieres, Quebec, Canada, G8Z 4K8
Aalborg, Denmark, 9100
Hillerød, Denmark, 3400
Roskilde, Denmark, 4000
Tampere, Finland, 33521
Turku, Finland, 20521
Auch, France, 32000
Bordeaux, France, 33000
Boulogne, France, 62321
Castelnau Le Lez, France, 34170
Cergy Pontoise, France, 95303
Chamalieres, France, 63400
Dijon, France, 21079
Fleury-merogis, France, 91712
Herouville Saint Clair, France, 14202
La Tronche, France, 38701
Lyon, France, 69437
Montpellier, France, 34295
Nimes, France, 30029
Paris, France, 75015
Paris, France, 75970
Reims, France, 51092
Rennes, France, 35033
Saint Herblain, France, 44093
Saint Ouen, France, 93400
St Brieuc, France, 22027
Villeurbanne, France, 69100
Bad Hersfeld, Germany, 36251
Bonn, Germany, 53127
Dortmund, Germany, 44263
München, Germany, 80804
Stuttgart, Germany, 70191
Villingen-schwenningen, Germany, 78054
Bologna, Italy, 40138
Como, Italy, 22100
Genova, Italy, 16132
Lecco, Italy, 23900
Modena, Italy, 41100
Pavia, Italy, 27100
Prato, Italy, 50047
Venezia, Italy, 30122
Amsterdam, Netherlands, 1081 HV
Dordrecht, Netherlands, 3318 AT
Leiria, Portugal, 2400-441
Alicante, Spain, 03010
Badalona, Spain, 08915
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Bilbao, Spain, 48013
Córdoba, Spain, 14004
Leon, Spain, 24071
Madrid, Spain, 28003
Madrid, Spain, 28035
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28222
Orense, Spain, 32005
Santander, Spain, 39008
Vigo, Spain, 36204
Vigo, Spain, 36205
Aarau, Switzerland, 5001
Lausanne, Switzerland, 1003
United Kingdom
Belfast, United Kingdom, BT9 7LJ
Canterbury, United Kingdom, CT1 3NE
Glasgow, United Kingdom, G4 OSF
London, United Kingdom, SE22 8PT
Manchester, United Kingdom, M13 9WL
Truro, United Kingdom, TR1 3LJ
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: NCT00394953    
Other Study ID Numbers: BH17847
First Posted: November 2, 2006    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa