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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Experimental | 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 Beta or Darbepoetin Alfa | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. | Weeks 16-24 |
| Measure | Description | 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. | Weeks 16-24 | |
| Dose adjustments, RBC transfusions, AEs. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbeville | 80103 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | 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. | |
| 26965694 | Derived | 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. |
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|
| Epoetin Beta | Drug | 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 Alfa | Drug | 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. |
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| Albi |
| 81030 |
| France |
| Amilly | 45200 | France |
| Angers | 49933 | France |
| Annonay | 07103 | France |
| Antony | 92166 | France |
| Aubagne | 13400 | France |
| Aulnay-sous-Bois | 93604 | France |
| Avignon | 84902 | France |
| Bagnols-sur-Cèze | 30200 | France |
| Beauvais | 60021 | France |
| Besançon | 25030 | France |
| Beuvry | 62660 | France |
| Béziers | 34525 | France |
| Bois-Bernard | 62320 | France |
| Bordeaux | 33077 | France |
| Brest | 29200 | France |
| Cabestany | 66330 | France |
| Caen | 14033 | France |
| Cannes | 06401 | France |
| Carpentras | 84200 | France |
| Castelnau-le-Lez | 34170 | France |
| Chamalières | 63400 | France |
| Charleville-Mézières | 08011 | France |
| Clermont-Ferrand | 63003 | France |
| Colmar | 68024 | France |
| Compiègne | 60200 | France |
| Creil | 60109 | France |
| Créteil | 94010 | France |
| Dijon | 21000 | France |
| Draguignan | 83300 | France |
| Évry | 91035 | France |
| Fleury-Mérogis | 91700 | France |
| Hyères | 83400 | France |
| La Chaussée-Saint-Victor | 41260 | France |
| La Rochelle | 17019 | France |
| La Tronche | 38701 | France |
| Le Mans | 72037 | France |
| Le Petit-Quevilly | 76143 | France |
| Le Port-Marly | 78560 | France |
| Lille | 59037 | France |
| Lille | 59042 | France |
| Lliie | 59003 | France |
| Lyon | 69008 | France |
| Manosque | 04100 | France |
| Marseille | 13008 | France |
| Marseille | 13253 | France |
| Meaux | 77104 | France |
| Metz | 57003 | France |
| Montpellier | 34295 | France |
| Mulhouse | 68070 | France |
| Muret | 31600 | France |
| Nantes | 44035 | France |
| Orléans | 45000 | France |
| Paris | 75 016 | France |
| Paris | 75008 | France |
| Paris | 75013 | France |
| Paris | 75015 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75970 | France |
| Perpignan | 66046 | France |
| Pessac | 33608 | France |
| Pierre-Bénite | 69495 | France |
| Poissy | 78303 | France |
| Poitiers | 86021 | France |
| Quincy-sous-Sénart | 91480 | France |
| Reims | 51092 | France |
| Rouen | 76040 | France |
| Rueil-Malmaison | 92500 | France |
| Saint-Benoît | 97470 | France |
| Saint-Brieuc | 22027 | France |
| Saint-Denis | 97405 | France |
| Saint-Maurice | 94415 | France |
| Saint-Ouen | 93400 | France |
| Saint-Pierre-des-Corps | 97448 | France |
| Saint-Priest-en-Jarez | 42277 | France |
| Saint-Quentin | 02100 | France |
| Saintes | 17108 | France |
| Strasbourg | 67200 | France |
| Tassin-la-Demi-Lune | 69150 | France |
| Toulon | 83056 | France |
| Toulouse | 31059 | France |
| Toulouse | 31077 | France |
| Trappes | 78190 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Vannes | 56017 | France |
| Vienne | 38209 | France |
| Villeurbanne | 69626 | France |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
| C103998 | epoetin beta |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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