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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • longterm hemodialysis for >=12 weeks before screening;
  • baseline Hb between 10 and 13g/dL;
  • iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

  • acute or chronic bleeding within 8 weeks prior to screening;
  • transfusion of red blood cells within 8 weeks prior to screening;
  • poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
  • previous treatment with Mircera.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

Secondary Outcome Measures

Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase. Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.
Percentage of Participants With Hb Fluctuations Within Screening Phase
Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.
Percentage of Participants Requiring Erythrocyte Transfusions

Full Information

First Posted
December 19, 2006
Last Updated
January 17, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00413894
Brief Title
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Official Title
An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa
Primary Outcome Measure Information:
Title
Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase
Time Frame
Visits 8 to 10 (Months 6 to 8)
Title
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase
Time Frame
Visits 8 to 10 (Months 6 to 8)
Title
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase
Description
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Time Frame
Visits 8 to 10 (Months 6 to 8)
Title
Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase
Description
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Time Frame
Visits 8 to 10 (Months 6 to 8)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase
Time Frame
Visits 1 to 2 (Months -2 to -1)
Title
Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase
Time Frame
Visits 1 to 2 (Months -2 to -1)
Title
Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase
Description
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Time Frame
Visits 1 to 2 (Months -2 to -1)
Title
Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase
Description
Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.
Time Frame
Visits 1 to 2 (Months -2 to -1)
Title
Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels
Description
Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase. Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.
Time Frame
Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)
Title
Percentage of Participants With Hb Fluctuations Within Evaluation Phase
Description
Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.
Time Frame
Visits 8 to 10 (Months 6 to 8)
Title
Percentage of Participants With Hb Fluctuations Within Screening Phase
Description
Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.
Time Frame
Visits 1 to 2 (Months -2 to -1)
Title
Percentage of Participants Requiring Erythrocyte Transfusions
Time Frame
Visits 1 to 10 (Months -2 to 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, >=18 years of age; chronic renal anemia; longterm hemodialysis for >=12 weeks before screening; baseline Hb between 10 and 13g/dL; iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening. Exclusion Criteria: acute or chronic bleeding within 8 weeks prior to screening; transfusion of red blood cells within 8 weeks prior to screening; poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months; previous treatment with Mircera.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Aachen
ZIP/Postal Code
52066
Country
Germany
City
Aachen
ZIP/Postal Code
52074
Country
Germany
City
Alzey
ZIP/Postal Code
55232
Country
Germany
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
City
Augsburg
ZIP/Postal Code
86157
Country
Germany
City
Bad König
ZIP/Postal Code
64732
Country
Germany
City
Bad Neundorf
ZIP/Postal Code
31542
Country
Germany
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
City
Bad Orb
ZIP/Postal Code
63619
Country
Germany
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10249
Country
Germany
City
Berlin
ZIP/Postal Code
12045
Country
Germany
City
Berlin
ZIP/Postal Code
12099
Country
Germany
City
Berlin
ZIP/Postal Code
12247
Country
Germany
City
Bochum
ZIP/Postal Code
44789
Country
Germany
City
Bottrop
ZIP/Postal Code
46242
Country
Germany
City
Bovenden
ZIP/Postal Code
37120
Country
Germany
City
Braunschweig
ZIP/Postal Code
38118
Country
Germany
City
Bremen
ZIP/Postal Code
28277
Country
Germany
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
City
Darmstadt
ZIP/Postal Code
64925
Country
Germany
City
Daun
ZIP/Postal Code
54550
Country
Germany
City
Demmin
ZIP/Postal Code
17109
Country
Germany
City
Dessau
ZIP/Postal Code
06847
Country
Germany
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40625
Country
Germany
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Frankfurt Am Main
ZIP/Postal Code
60596
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Freiburg
ZIP/Postal Code
97110
Country
Germany
City
Freudenstadt
ZIP/Postal Code
72250
Country
Germany
City
Fulda
ZIP/Postal Code
36043
Country
Germany
City
Fürstenzell
ZIP/Postal Code
94081
Country
Germany
City
Fürth
ZIP/Postal Code
90766
Country
Germany
City
Gelsenkirchen
ZIP/Postal Code
45886
Country
Germany
City
Gelsenkirchen
ZIP/Postal Code
45894
Country
Germany
City
Gerolstein
ZIP/Postal Code
54568
Country
Germany
City
Giessen
ZIP/Postal Code
35392
Country
Germany
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
City
Halle
ZIP/Postal Code
06120
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
City
Hann. Münden
ZIP/Postal Code
34346
Country
Germany
City
Harsewinkel
ZIP/Postal Code
33428
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Heide
ZIP/Postal Code
25746
Country
Germany
City
Heilbronn
ZIP/Postal Code
74076
Country
Germany
City
Hildesheim
ZIP/Postal Code
31139
Country
Germany
City
Homburg/saar
ZIP/Postal Code
66424
Country
Germany
City
Homburg
ZIP/Postal Code
66421
Country
Germany
City
Idar-oberstein
ZIP/Postal Code
55743
Country
Germany
City
Jena
ZIP/Postal Code
07751
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Krefeld
ZIP/Postal Code
47798
Country
Germany
City
Köln
ZIP/Postal Code
51109
Country
Germany
City
Lauterbach
ZIP/Postal Code
36341
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
City
Lennestadt
ZIP/Postal Code
57368
Country
Germany
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
City
Marburg
ZIP/Postal Code
35043
Country
Germany
City
Marl
ZIP/Postal Code
45768
Country
Germany
City
Meiningen
ZIP/Postal Code
98617
Country
Germany
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
City
Minden
ZIP/Postal Code
32425
Country
Germany
City
Mönchengladbach
ZIP/Postal Code
41236
Country
Germany
City
München
ZIP/Postal Code
81545
Country
Germany
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
City
Oberschleissheim
ZIP/Postal Code
85764
Country
Germany
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
City
Potsdam
ZIP/Postal Code
14482
Country
Germany
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
City
Ribnitz-damgarten
ZIP/Postal Code
18311
Country
Germany
City
Rostock
ZIP/Postal Code
18057
Country
Germany
City
Rostock
ZIP/Postal Code
18107
Country
Germany
City
Saarbrücken
ZIP/Postal Code
6119
Country
Germany
City
Schloss Holte-stutenbrock
ZIP/Postal Code
38758
Country
Germany
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
City
Schwerin
ZIP/Postal Code
19057
Country
Germany
City
Schwetzingen
ZIP/Postal Code
68723
Country
Germany
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
City
Trier
ZIP/Postal Code
54292
Country
Germany
City
Waiblingen
ZIP/Postal Code
71334
Country
Germany
City
Weinheim
ZIP/Postal Code
69469
Country
Germany
City
Weinheim
ZIP/Postal Code
79539
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
City
Wiesloch
ZIP/Postal Code
69168
Country
Germany
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
City
Würzburg
ZIP/Postal Code
97072
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26965694
Citation
Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
Results Reference
derived
PubMed Identifier
20225992
Citation
Fliser D, Kleophas W, Dellanna F, Winkler RE, Backs W, Kraatz U, Fassbinder W, Wizemann V, Strack G. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010 May;26(5):1083-9. doi: 10.1185/03007991003666652. Erratum In: Curr Med Res Opin. 2010 Aug;26(8):1826. Dellana, F [corrected to Dellanna, F].
Results Reference
derived

Learn more about this trial

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

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