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poor recruitment
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This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration between baseline and efficacy evaluation period (EEP). | Weeks 13-16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions. | Throughout study | |
| SF36 | Weeks 16 and 48 |
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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 |
|---|---|---|---|---|---|---|
| Edegem | Belgium | |||||
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| Supportive treatment | Drug | As prescribed |
|
| AEs, laboratory parameters. | Throughout study |
| Ghent |
| Belgium |
| Leuven | Belgium |
| Amiens | France |
| Caen | France |
| Le Kremlin-Bicêtre | France |
| Nice | France |
| Paris | France |
| Toulouse | France |
| Tours | France |
| Berlin | Germany |
| Frankfurt am Main | Germany |
| Kaiserslautern | Germany |
| Kiel | Germany |
| München | Germany |
| Bari | Italy |
| Barcelona | Spain |
| Santander | Spain |
| Seville | Spain |
| London | United Kingdom |
| 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 |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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