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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005757-28 | EudraCT Number |
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This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Experimental | Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Drug | Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period | Weeks 16-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Hb concentration | Between reference and Efficacy Evaluation Period | |
| Mean time spent in Hb range | Weeks 16-24 | |
| % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions |
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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 |
|---|---|---|---|---|---|---|
| Aix-en-Provence | 13090 | France | ||||
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|
|
| Weeks 16-48 |
| AEs, lab parameters | Throughout study |
| Angers |
| 49000 |
| France |
| Angers | 49933 | France |
| Annonay | 07103 | France |
| Avignon | 84902 | France |
| Bastia | 20604 | France |
| Beauvais | 60000 | France |
| Besançon | 25030 | France |
| Bois-Guillaume | 76233 | France |
| Bordeaux | 33077 | France |
| Boulogne-sur-Mer | 62321 | France |
| Bourg-en-Bresse | 01012 | France |
| Bourges | 18020 | France |
| Brest | 29609 | France |
| Caen | 14033 | France |
| Chalon-sur-Saône | 71100 | France |
| Chartres | 28000 | France |
| Cherbourg Octeville | 50102 | France |
| Cholet | 49300 | France |
| Clermont-Ferrand | 63058 | France |
| Colmar | 68024 | France |
| Creil | 60100 | France |
| Créteil | 94010 | France |
| Dieppe | 76202 | France |
| Évreux | 27023 | France |
| Greize | 69400 | France |
| Harfleur | 76700 | France |
| La Garenne-Colombes | 92250 | France |
| La Tronche | 38701 | France |
| Le Havre | 76083 | France |
| Le Mans | 72037 | France |
| Lille | 59042 | France |
| Limoges | 87042 | France |
| Lyon | 69437 | France |
| Maubeuge | 59604 | France |
| Metz | 57045 | France |
| Metz-Tessy | 74370 | France |
| Montluçon | 03108 | France |
| Montpellier | 34097 | France |
| Montpellier | 34295 | France |
| Nancy | 54100 | France |
| Nice | 06002 | France |
| Nîmes | 30006 | France |
| Orléans | 45000 | France |
| Paris | 75018 | France |
| Paris | 75651 | France |
| Paris | 75743 | France |
| Paris | 75908 | France |
| Paris | 75970 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Quimper | 29000 | France |
| Roubaix | 59056 | France |
| Saint-Brieuc | 22027 | France |
| Saint-Laurent-du-Var | 06721 | France |
| Saint-Lô | 50009 | France |
| Saint-Michel | 16470 | France |
| Saint-Nazaire | 44606 | France |
| Salouël | 80480 | France |
| Sens | 89108 | France |
| St-Malo | 35043 | France |
| Strasbourg | 67091 | France |
| Suresnes | 92151 | France |
| Thionville | 57126 | France |
| Toulouse | 31059 | France |
| Tournan-en-Brie | 77220 | France |
| Valenciennes | 59300 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Vannes | 56017 | 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 |
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