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

September 9, 2021 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

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

  • France
      • Abbeville, France, 80103
      • Albi, France, 81030
      • Amilly, France, 45200
      • Angers, France, 49933
      • Annonay, France, 07103
      • Antony, France, 92166
      • Aubagne, France, 13400
      • Aulnay Sous Bois, France, 93604
      • Avignon, France, 84902
      • Bagnols Sur Ceze, France, 30200
      • Beauvais, France, 60021
      • Besancon, France, 25030
      • Beuvry, France, 62660
      • Beziers, France, 34525
      • Bois Bernard, France, 62320
      • Bordeaux, France, 33077
      • Brest, France, 29200
      • Cabestany, France, 66330
      • Caen, France, 14033
      • Cannes, France, 06401
      • Carpentras, France, 84200
      • Castelnau le Lez, France, 34170
      • Chamalieres, France, 63400
      • Charleville Mezieres, France, 08011
      • Clermont-ferrand, France, 63003
      • Colmar, France, 68024
      • Compiegne, France, 60200
      • Creil, France, 60109
      • Creteil, France, 94010
      • Dijon, France, 21000
      • Draguignan, France, 83300
      • Evry, France, 91035
      • Fleury Merogis, France, 91700
      • Hyeres, France, 83400
      • La Chaussee St Victor, France, 41260
      • La Rochelle, France, 17019
      • La Tronche, France, 38701
      • Le Mans, France, 72037
      • Le Petit Quevilly, France, 76143
      • Le Port Marly, France, 78560
      • Lille, France, 59037
      • Lille, France, 59042
      • Lliie, France, 59003
      • Lyon, France, 69008
      • Manosque, France, 04100
      • Marseille, France, 13008
      • Marseille, France, 13253
      • Meaux, France, 77104
      • Metz, France, 57003
      • Montpellier, France, 34295
      • Mulhouse, France, 68070
      • Muret, France, 31600
      • Nantes, France, 44035
      • Orleans, France, 45000
      • Paris, France, 75013
      • Paris, France, 75 016
      • Paris, France, 75970
      • Paris, France, 75651
      • Paris, France, 75674
      • Paris, France, 75015
      • Paris, France, 75008
      • Perpignan, France, 66046
      • Pessac, France, 33608
      • Pierre Benite, France, 69495
      • Poissy, France, 78303
      • Poitiers, France, 86021
      • Quincy Sous Senart, France, 91480
      • Reims, France, 51092
      • Rouen, France, 76040
      • Rueil Malmaison, France, 92500
      • Saint Ouen, France, 93400
      • Saintes, France, 17108
      • St Benoit, France, 97470
      • St Brieuc, France, 22027
      • St Denis, France, 97405
      • St Maurice, France, 94415
      • St Ouen, France, 93400
      • St Pierre, France, 97448
      • St Priest En Jarez, France, 42277
      • St Quentin, France, 02100
      • Strasbourg, France, 67200
      • Tassin, France, 69150
      • Toulon, France, 83056
      • Toulouse, France, 31059
      • Toulouse, France, 31077
      • Trappes, France, 78190
      • Vandoeuvre-les-nancy, France, 54511
      • Vannes, France, 56017
      • Vienne, France, 38209
      • Villeurbanne, France, 69626

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:

  • 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

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
EXPERIMENTAL: Methoxy Polyethylene Glycol-epoetin Beta
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.
Drug: Methoxy Polyethylene Glycol-epoetin Beta
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.
Other Names:
  • Mircera
  • C.E.R.A
ACTIVE_COMPARATOR: Epoetin Beta or Darbepoetin Alfa
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.
Drug: Epoetin Beta
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.
Drug: Darbepoetin Alfa
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
Time Frame: Weeks 16-24
Weeks 16-24

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Weeks 16-24
Dose adjustments, RBC transfusions, AEs.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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.

General Publications

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

August 1, 2008

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (ESTIMATE)

July 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21145

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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