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A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methoxy Polyethylene Glycol-epoetin Beta
Epoetin Beta
Darbepoetin Alfa
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:

  • regular long term hemodialysis with same schedule for greater than or equal to (>=) 12 weeks
  • continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months
  • significant acute or chronic bleeding
  • poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
  • weekly dose of epoetin beta greater than (>) 16000 international units (IU), or weekly dose of darbepoetin alfa >80 micrograms during previous month

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methoxy Polyethylene Glycol-epoetin Beta

Epoetin Beta or Darbepoetin Alfa

Arm Description

Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.

Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will continue to receive the same treatment (epoetin beta or darbepoetin alfa at the same dose, same administration intervals, and the same route of administration). When necessary, dose adjustments will be performed according to Summary of Product Characteristics (SmPC). Total duration of treatment will be up to 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.

Secondary Outcome Measures

Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.
Dose adjustments, RBC transfusions, AEs.

Full Information

First Posted
July 16, 2008
Last Updated
September 9, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00717821
Brief Title
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
Official Title
A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxy Polyethylene Glycol-epoetin Beta
Arm Type
Experimental
Arm Description
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
Arm Title
Epoetin Beta or Darbepoetin Alfa
Arm Type
Active Comparator
Arm Description
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will continue to receive the same treatment (epoetin beta or darbepoetin alfa at the same dose, same administration intervals, and the same route of administration). When necessary, dose adjustments will be performed according to Summary of Product Characteristics (SmPC). Total duration of treatment will be up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Methoxy Polyethylene Glycol-epoetin Beta
Other Intervention Name(s)
Mircera, C.E.R.A
Intervention Description
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Epoetin Beta
Intervention Description
Participants who are receiving SC or IV epoetin beta will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Darbepoetin Alfa
Intervention Description
Participants who are receiving SC or IV darbepoetin alfa will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
Time Frame
Weeks 16-24
Secondary Outcome Measure Information:
Title
Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.
Time Frame
Weeks 16-24
Title
Dose adjustments, RBC transfusions, AEs.
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: regular long term hemodialysis with same schedule for greater than or equal to (>=) 12 weeks continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose Exclusion Criteria: transfusion of red blood cells during previous 2 months significant acute or chronic bleeding poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months weekly dose of epoetin beta greater than (>) 16000 international units (IU), or weekly dose of darbepoetin alfa >80 micrograms during previous month
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
Abbeville
ZIP/Postal Code
80103
Country
France
City
Albi
ZIP/Postal Code
81030
Country
France
City
Amilly
ZIP/Postal Code
45200
Country
France
City
Angers
ZIP/Postal Code
49933
Country
France
City
Annonay
ZIP/Postal Code
07103
Country
France
City
Antony
ZIP/Postal Code
92166
Country
France
City
Aubagne
ZIP/Postal Code
13400
Country
France
City
Aulnay Sous Bois
ZIP/Postal Code
93604
Country
France
City
Avignon
ZIP/Postal Code
84902
Country
France
City
Bagnols Sur Ceze
ZIP/Postal Code
30200
Country
France
City
Beauvais
ZIP/Postal Code
60021
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Beuvry
ZIP/Postal Code
62660
Country
France
City
Beziers
ZIP/Postal Code
34525
Country
France
City
Bois Bernard
ZIP/Postal Code
62320
Country
France
City
Bordeaux
ZIP/Postal Code
33077
Country
France
City
Brest
ZIP/Postal Code
29200
Country
France
City
Cabestany
ZIP/Postal Code
66330
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Cannes
ZIP/Postal Code
06401
Country
France
City
Carpentras
ZIP/Postal Code
84200
Country
France
City
Castelnau le Lez
ZIP/Postal Code
34170
Country
France
City
Chamalieres
ZIP/Postal Code
63400
Country
France
City
Charleville Mezieres
ZIP/Postal Code
08011
Country
France
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Compiegne
ZIP/Postal Code
60200
Country
France
City
Creil
ZIP/Postal Code
60109
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
Draguignan
ZIP/Postal Code
83300
Country
France
City
Evry
ZIP/Postal Code
91035
Country
France
City
Fleury Merogis
ZIP/Postal Code
91700
Country
France
City
Hyeres
ZIP/Postal Code
83400
Country
France
City
La Chaussee St Victor
ZIP/Postal Code
41260
Country
France
City
La Rochelle
ZIP/Postal Code
17019
Country
France
City
La Tronche
ZIP/Postal Code
38701
Country
France
City
Le Mans
ZIP/Postal Code
72037
Country
France
City
Le Petit Quevilly
ZIP/Postal Code
76143
Country
France
City
Le Port Marly
ZIP/Postal Code
78560
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lille
ZIP/Postal Code
59042
Country
France
City
Lliie
ZIP/Postal Code
59003
Country
France
City
Lyon
ZIP/Postal Code
69008
Country
France
City
Manosque
ZIP/Postal Code
04100
Country
France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Marseille
ZIP/Postal Code
13253
Country
France
City
Meaux
ZIP/Postal Code
77104
Country
France
City
Metz
ZIP/Postal Code
57003
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Mulhouse
ZIP/Postal Code
68070
Country
France
City
Muret
ZIP/Postal Code
31600
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Orleans
ZIP/Postal Code
45000
Country
France
City
Paris
ZIP/Postal Code
75 016
Country
France
City
Paris
ZIP/Postal Code
75008
Country
France
City
Paris
ZIP/Postal Code
75013
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Perpignan
ZIP/Postal Code
66046
Country
France
City
Pessac
ZIP/Postal Code
33608
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Poissy
ZIP/Postal Code
78303
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Quincy Sous Senart
ZIP/Postal Code
91480
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Rouen
ZIP/Postal Code
76040
Country
France
City
Rueil Malmaison
ZIP/Postal Code
92500
Country
France
City
Saint Ouen
ZIP/Postal Code
93400
Country
France
City
Saintes
ZIP/Postal Code
17108
Country
France
City
St Benoit
ZIP/Postal Code
97470
Country
France
City
St Brieuc
ZIP/Postal Code
22027
Country
France
City
St Denis
ZIP/Postal Code
97405
Country
France
City
St Maurice
ZIP/Postal Code
94415
Country
France
City
St Ouen
ZIP/Postal Code
93400
Country
France
City
St Pierre
ZIP/Postal Code
97448
Country
France
City
St Priest En Jarez
ZIP/Postal Code
42277
Country
France
City
St Quentin
ZIP/Postal Code
02100
Country
France
City
Strasbourg
ZIP/Postal Code
67200
Country
France
City
Tassin
ZIP/Postal Code
69150
Country
France
City
Toulon
ZIP/Postal Code
83056
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Toulouse
ZIP/Postal Code
31077
Country
France
City
Trappes
ZIP/Postal Code
78190
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Vannes
ZIP/Postal Code
56017
Country
France
City
Vienne
ZIP/Postal Code
38209
Country
France
City
Villeurbanne
ZIP/Postal Code
69626
Country
France

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

Learn more about this trial

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

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