Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin beta | Experimental | Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin beta | Drug | Participants will receive epoetin beta as a weekly subcutaneous (SC) injection over an 8-week correction phase with 60 international units per kilograms (IU/kg) as starting dose. Baseline weight will be used to determine the dose and adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. Participants with a response to correction treatment will then enter a 4-week extension phase to receive the SC injection every 2 weeks, and those without response will continue at the same weekly dose for a 4-week continuation phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Extension Phase | Week 12 | |
| Percentage of Participants With Hemoglobin >11 g/dL After 4-Week Continuation Phase | Week 12 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-en-Provence | 13090 | France | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Quality of Life of Participants as Assessed From Short Form 36 (SF-36) Scores |
| Baseline, Week 8, 12 |
| Percentage of Participants With Positive Response to Questionnaire for Practicality and Safety of Self-administration of Study Drug | Week 8, 12 |
| Number of Participants With Local Injection Site Reactions | Up to 12 weeks |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 12 weeks |
| Number of Participants With Chronic Kidney Disease | Baseline |
| Response to Treatment at the end of the Correction Phase Among Participants With Different Time Since Diabetes Diagnosis | Week 8 |
| Response to Treatment at the end of the Correction Phase Among Participants With Different Hemoglobin Levels at Baseline | Week 8 |
| Response to Treatment at the end of the Correction Phase Among Participants With Different Hematocrit at Baseline | Week 8 |
| Number of Participants per Category of History of Medical Disorders and Surgical Procedures | Baseline |
| Number of Participants per Type of Diabetes | Week 8, 12 |
| Angers |
| 49000 |
| France |
| Annonay | 07103 | France |
| Arras | 62022 | France |
| Aubervilliers | 93300 | France |
| Beauvais | 60000 | France |
| Besançon | 25030 | France |
| Béziers | 34500 | France |
| Blois | 4100 | France |
| Bois-Bernard | 62320 | France |
| Bois-Guillaume | 76233 | France |
| Bordeaux | 33000 | France |
| Bordeaux | 33076 | France |
| Bordeaux | 33077 | France |
| Boulogne | 62321 | France |
| Bourg-en-Bresse | 01012 | France |
| Bourgoin | 38317 | France |
| Brivé | 19312 | France |
| Cabestany | 66330 | France |
| Chamalières | 63400 | France |
| Chartres | 28000 | France |
| Clermont-Ferrand | 63058 | France |
| Colmar | 68024 | France |
| Creil | 60100 | France |
| Créteil | 94010 | France |
| Dijon | 21079 | France |
| Évian-les-Bains | 74500 | France |
| Évreux | 27023 | France |
| Évry | 91014 | France |
| Figanières | 83830 | France |
| Gap | 05000 | France |
| Greize | 69400 | France |
| Haguenau | 67504 | France |
| Harfleur | 76700 | France |
| La Roche-sur-Yon | 85925 | France |
| La Tronche | 38700 | France |
| Le Havre | 76083 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Le Mans | 72037 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Marseille | 13362 | France |
| Martigues | 13500 | France |
| Maubeuge | 59604 | France |
| Melun | 77011 | France |
| Mont-de-Marsan | 40024 | France |
| Montpellier | 34097 | France |
| Montreuil | 93105 | France |
| Muret | 31603 | France |
| Nevers | 58033 | France |
| Niort | 79021 | France |
| Nîmes | 30932 | France |
| Orléans | 45000 | France |
| Paris | 75017 | France |
| Paris | 75651 | France |
| Paris | 75908 | France |
| Pierre-Bénite | 69495 | France |
| Poissy | 78303 | France |
| Poitiers | 86021 | France |
| Quimper | 29000 | France |
| Reims | 51092 | France |
| Rouen | 76100 | France |
| Saint-Brieuc | 22027 | France |
| Saint-Laurent-du-Var | 06721 | France |
| Saint-Lô | 50009 | France |
| Saint-Maurice | 94415 | France |
| Saintes | 17108 | France |
| Salouël | 80480 | France |
| Sens | 89108 | France |
| Thiais | 94320 | France |
| Thionville | 57126 | France |
| Toulouse | 31059 | France |
| Tournan-en-Brie | 77220 | France |
| Trappes | 78190 | France |
| Valence | 26953 | France |
| Valence | 30029 | France |
| Valenciennes | 59300 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C103998 | epoetin beta |
Not provided
Not provided
Not provided