Clinical Trial Details
| Trial ID: | L1754 |
| Source ID: | NCT00413894 |
| Associated Drug: | Methoxy Polyethylene Glycol-Epoetin Beta [Mircera] |
| Title: | A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00413894/results |
| Conditions: | Anemia |
| Interventions: | DRUG: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Outcome Measures: | Primary: Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase, Visits 8 to 10 (Months 6 to 8)|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase, Visits 8 to 10 (Months 6 to 8)|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase, Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported., Visits 8 to 10 (Months 6 to 8)|Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase, Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported., Visits 8 to 10 (Months 6 to 8) | Secondary: Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase, Visits 1 to 2 (Months -2 to -1)|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase, Visits 1 to 2 (Months -2 to -1)|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase, Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported., Visits 1 to 2 (Months -2 to -1)|Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase, Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported., Visits 1 to 2 (Months -2 to -1)|Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels, Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase. Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted., Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)|Percentage of Participants With Hb Fluctuations Within Evaluation Phase, Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (\>) ±1.0 to ±1.5 g/dL, \> ±1.5 to ±2.0 g/dL, and \> ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study., Visits 8 to 10 (Months 6 to 8)|Percentage of Participants With Hb Fluctuations Within Screening Phase, Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, \>±1.0 to ±1.5 g/dL, \>±1.5 to ±2.0 g/dL, and \>±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study., Visits 1 to 2 (Months -2 to -1)|Percentage of Participants Requiring Erythrocyte Transfusions, Visits 1 to 10 (Months -2 to 8) |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 424 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2007-03 |
| Completion Date: | 2008-10 |
| Results First Posted: | 2016-02-15 |
| Last Update Posted: | 2016-02-15 |
| Locations: | Aachen, 52066, Germany|Aachen, 52074, Germany|Alzey, 55232, Germany|Ansbach, 91522, Germany|Augsburg, 86157, Germany|Bad König, 64732, Germany|Bad Neundorf, 31542, Germany|Bad Oeynhausen, 32545, Germany|Bad Orb, 63619, Germany|Bayreuth, 95445, Germany|Berlin, 10117, Germany|Berlin, 10249, Germany|Berlin, 12045, Germany|Berlin, 12099, Germany|Berlin, 12247, Germany|Bochum, 44789, Germany|Bottrop, 46242, Germany|Bovenden, 37120, Germany|Braunschweig, 38118, Germany|Bremen, 28277, Germany|Coesfeld, 48653, Germany|Darmstadt, 64295, Germany|Darmstadt, 64925, Germany|Daun, 54550, Germany|Demmin, 17109, Germany|Dessau, 06847, Germany|Dortmund, 44263, Germany|Düsseldorf, 40210, Germany|Düsseldorf, 40225, Germany|Düsseldorf, 40625, Germany|Erfurt, 99089, Germany|Essen, 45122, Germany|Frankfurt Am Main, 60596, Germany|Freiburg, 79106, Germany|Freiburg, 97110, Germany|Freudenstadt, 72250, Germany|Fulda, 36043, Germany|Fürstenzell, 94081, Germany|Fürth, 90766, Germany|Gelsenkirchen, 45886, Germany|Gelsenkirchen, 45894, Germany|Gerolstein, 54568, Germany|Giessen, 35392, Germany|Greifswald, 17489, Germany|Göttingen, 37075, Germany|Gütersloh, 33332, Germany|Halle, 06120, Germany|Hamburg, 20246, Germany|Hamburg, 22297, Germany|Hann. Münden, 34346, Germany|Harsewinkel, 33428, Germany|Heidelberg, 69120, Germany|Heide, 25746, Germany|Heilbronn, 74076, Germany|Hildesheim, 31139, Germany|Homburg/saar, 66424, Germany|Homburg, 66421, Germany|Idar-oberstein, 55743, Germany|Jena, 07751, Germany|Karlsruhe, 76133, Germany|Kiel, 24105, Germany|Krefeld, 47798, Germany|Köln, 51109, Germany|Lauterbach, 36341, Germany|Leipzig, 04103, Germany|Leipzig, 04129, Germany|Lennestadt, 57368, Germany|Ludwigsburg, 71640, Germany|Ludwigshafen, 67063, Germany|Lüdenscheid, 58515, Germany|Marburg, 35043, Germany|Marl, 45768, Germany|Meiningen, 98617, Germany|Memmingen, 87700, Germany|Minden, 32425, Germany|Mönchengladbach, 41236, Germany|München, 81545, Germany|Neuruppin, 16816, Germany|Oberschleissheim, 85764, Germany|Offenbach, 63069, Germany|Offenburg, 77654, Germany|Potsdam, 14482, Germany|Recklinghausen, 45659, Germany|Regensburg, 93053, Germany|Reutlingen, 72764, Germany|Ribnitz-damgarten, 18311, Germany|Rostock, 18057, Germany|Rostock, 18107, Germany|Saarbrücken, 6119, Germany|Schloss Holte-stutenbrock, 38758, Germany|Schwerin, 19049, Germany|Schwerin, 19057, Germany|Schwetzingen, 68723, Germany|Stralsund, 18435, Germany|Stuttgart, 70199, Germany|Stuttgart, 70376, Germany|Trier, 54292, Germany|Waiblingen, 71334, Germany|Weinheim, 69469, Germany|Weinheim, 79539, Germany|Wiesbaden, 65191, Germany|Wiesloch, 69168, Germany|Wuppertal, 42103, Germany|Wuppertal, 42283, Germany|Würzburg, 97072, Germany |
| URL: | https://clinicaltrials.gov/show/NCT00413894 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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