Clinical Trial Details
| Trial ID: | L1691 |
| Source ID: | NCT02827266 |
| Associated Drug: | Epoetin Beta |
| Title: | A Study of Epoetin Beta (NeoRecormon) in Anemic Participants With Diabetes and Chronic Renal Failure Who Are Not on Dialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia |
| Interventions: | DRUG: Epoetin beta |
| Outcome Measures: | Primary: Percentage of Participants With Hemoglobin Greater Than (>) 11 Grams per Deciliter (g/dL) After 8-Week Correction Phase, Week 8 | Secondary: 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|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 |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 122 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2005-10 |
| Completion Date: | 2008-01 |
| Results First Posted: | |
| Last Update Posted: | 2016-07-11 |
| Locations: | Aix En Provence, 13090, France|Angers, 49000, France|Annonay, 07103, France|Arras, 62022, France|Aubervilliers, 93300, France|Beauvais, 60000, France|Besancon, 25030, France|Beziers, 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 Jallieu, 38317, France|Brive, 19312, France|Cabestany, 66330, France|Chamalieres, 63400, France|Chartres, 28000, France|Clermont-ferrand, 63058, France|Colmar, 68024, France|Creil, 60100, France|Creteil, 94010, France|Dijon, 21079, France|Evian Les Bains, 74500, France|Evreux, 27023, France|Evry, 91014, France|Figanieres, 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-bicetre, 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|Nimes, 30932, France|Niort, 79021, France|Orleans, 45000, France|Paris, 75017, France|Paris, 75651, France|Paris, 75908, France|Pierre Benite, 69495, France|Poissy, 78303, France|Poitiers, 86021, France|Quimper, 29000, France|Reims, 51092, France|Rouen, 76100, France|Saint Laurent Du Var, 06721, France|Saint Lo, 50009, France|Saintes, 17108, France|Salouel, 80480, France|Sens, 89108, France|St Brieuc, 22027, France|St Maurice, 94415, 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|Vandoeuvre-les-nancy, 54511, France |
| URL: | https://clinicaltrials.gov/show/NCT02827266 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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