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AnemiaPhase 3NCT00717821

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

A Phase 3 study testing Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta and Darbepoetin Alfa in people with Anemia, run by Hoffmann-La Roche at 89 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta and Darbepoetin Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
89 sitesFrance
Study dates
Aug 2008to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

89 sites in 1 country.

89 sites in 1 country

France89 sites

  • Study site

    Abbeville, 80103

  • Study site

    Albi, 81030

  • Study site

    Amilly, 45200

  • Study site

    Angers, 49933

  • Study site

    Annonay, 07103

  • Study site

    Antony, 92166

  • Study site

    Aubagne, 13400

  • Study site

    Aulnay-sous-Bois, 93604

  • Study site

    Avignon, 84902

  • Study site

    Bagnols-sur-Cèze, 30200

  • Study site

    Beauvais, 60021

  • Study site

    Besançon, 25030

  • Study site

    Beuvry, 62660

  • Study site

    Béziers, 34525

  • Study site

    Bois-Bernard, 62320

  • Study site

    Bordeaux, 33077

  • Study site

    Brest, 29200

  • Study site

    Cabestany, 66330

  • Study site

    Caen, 14033

  • Study site

    Cannes, 06401

  • Study site

    Carpentras, 84200

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Chamalières, 63400

  • Study site

    Charleville-Mézières, 08011

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Colmar, 68024

  • Study site

    Compiègne, 60200

  • Study site

    Creil, 60109

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21000

  • Study site

    Draguignan, 83300

  • Study site

    Évry, 91035

  • Study site

    Fleury-Mérogis, 91700

  • Study site

    Hyères, 83400

  • Study site

    La Chaussée-Saint-Victor, 41260

  • Study site

    La Rochelle, 17019

  • Study site

    La Tronche, 38701

  • Study site

    Le Mans, 72037

  • Study site

    Le Petit-Quevilly, 76143

  • Study site

    Le Port-Marly, 78560

  • Study site

    Lille, 59037

  • Study site

    Lille, 59042

  • Study site

    Lliie, 59003

  • Study site

    Lyon, 69008

  • Study site

    Manosque, 04100

  • Study site

    Marseille, 13008

  • Study site

    Marseille, 13253

  • Study site

    Meaux, 77104

  • Study site

    Metz, 57003

  • Study site

    Montpellier, 34295

  • Study site

    Mulhouse, 68070

  • Study site

    Muret, 31600

  • Study site

    Nantes, 44035

  • Study site

    Orléans, 45000

  • Study site

    Paris, 75 016

  • Study site

    Paris, 75008

  • Study site

    Paris, 75013

  • Study site

    Paris, 75015

  • Study site

    Paris, 75651

  • Study site

    Paris, 75674

  • Study site

    Paris, 75970

  • Study site

    Perpignan, 66046

  • Study site

    Pessac, 33608

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poissy, 78303

  • Study site

    Poitiers, 86021

  • Study site

    Quincy-sous-Sénart, 91480

  • Study site

    Reims, 51092

  • Study site

    Rouen, 76040

  • Study site

    Rueil-Malmaison, 92500

  • Study site

    Saint-Benoît, 97470

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Saint-Denis, 97405

  • Study site

    Saint-Maurice, 94415

  • Study site

    Saint-Ouen, 93400

  • Study site

    Saint-Pierre-des-Corps, 97448

  • Study site

    Saint-Priest-en-Jarez, 42277

  • Study site

    Saint-Quentin, 02100

  • Study site

    Saintes, 17108

  • Study site

    Strasbourg, 67200

  • Study site

    Tassin-la-Demi-Lune, 69150

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31059

  • Study site

    Toulouse, 31077

  • Study site

    Trappes, 78190

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Vannes, 56017

  • Study site

    Vienne, 38209

  • Study site

    Villeurbanne, 69626

Other trials in France

About this study

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

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).

Conditions
Anemia
Being tested
Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta, Darbepoetin Alfa
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methoxy Polyethylene Glycol-epoetin BetaDrug

    Also called Mircera, C.E.R.A

    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.

  • Epoetin BetaDrug

    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.

  • Darbepoetin AlfaDrug

    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.

Study groups in NCT00717821
Study groupRoleWhat they receive
Methoxy Polyethylene Glycol-epoetin BetaExperimentalParticipants 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.
Receives: Drug: Methoxy Polyethylene Glycol-epoetin Beta
Epoetin Beta or Darbepoetin AlfaActive comparatorParticipants 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.
Receives: Drug: Epoetin Beta; Drug: Darbepoetin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Weeks 16-24

Secondary outcomes (2)

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

    Measured: Weeks 16-24

  2. Dose adjustments, RBC transfusions, AEs.

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717821
Sponsor's protocol ID
ML21145
Status last verified
Sep 2021
First submitted
16 Jul 2008
Last updated
14 Sep 2021
Results posted
No

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

  • 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.

    PubMed 26965694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta and Darbepoetin Alfa in people with Anemia, run by Hoffmann-La Roche at 89 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. (time frame: Weeks 16-24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717821, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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