Clinical Trial Details
| Trial ID: | L1532 |
| Source ID: | NCT00442702 |
| Associated Drug: | Mircera |
| Title: | A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00442702/results |
| Conditions: | Anemia |
| Interventions: | DRUG: Mircera|DRUG: Darbepoetin alfa |
| Outcome Measures: | Primary: Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period, A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration., Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit). | Secondary: Change in Hemoglobin Concentration From Baseline Over Time, From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.|Number of Participants With Red Blood Cell (RBC) Transfusions, Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once., From randomization to Month 9|Participants With Adverse Events, Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period., Randomization to Month 10 (final visit) |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 228 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2007-09 |
| Completion Date: | 2010-08 |
| Results First Posted: | 2011-10-03 |
| Last Update Posted: | 2011-12-19 |
| Locations: | Granada Hills, California, 91344, United States|Lauderdale Lakes, Florida, 33313, United States|Augusta, Georgia, 30309, United States|Mineola, New York, 11501, United States|Orchard Park, New York, 14127, United States|Raleigh, North Carolina, 27609, United States|Oregon City, Oregon, 97045, United States|Providence, Rhode Island, 02903, United States|Chattanooga, Tennessee, 37404, United States|Salem, Virginia, 24153, United States|Morgantown, West Virginia, 26506, United States|Adelaide, SA 5000, Australia|Gosford, 2250, Australia|Lismore, 2480, Australia|Reservoir, 3073, Australia|Richmond, 3121, Australia|Aalst, 9300, Belgium|Roeselare, 8800, Belgium|Calgary, Alberta, T2N 2T9, Canada|St John's, Newfoundland and Labrador, A1B 3V6, Canada|Kingston, Ontario, K7L 3N6, Canada|Mississauga, Ontario, L5M 2V8, Canada|Toronto, Ontario, M5G 2C4, Canada|Toronto, Ontario, M9N 1N8, Canada|Montreal, Quebec, H2X 3J4, Canada|Marianske Lazne, 35301, Czech Republic|Praha 2, 128 08, Czech Republic|Praha 4, 14200, Czech Republic|Praha, 14021, Czech Republic|La Tronche, 38700, France|Nantes, 44035, France|Orleans, 45100, France|Paris, 75475, France|Rennes, 35033, France|St Priest En Jarez, 42277, France|Strasbourg, 67091, France|Bad Hersfeld, 36251, Germany|Bad König, 64732, Germany|Berlin, 13353, Germany|Bonn, 53127, Germany|Coburg, 96450, Germany|Demmin, 17109, Germany|Dortmund, 44263, Germany|München, 80331, Germany|Baja, 6500, Hungary|Budapest, 1071, Hungary|Esztergom, 2500, Hungary|Hodmezovasarhely, 6800, Hungary|Kalocsa, 6300, Hungary|Kecskemet, 6001, Hungary|Szigetvar, 7390, Hungary|VAC, 2600, Hungary|Hadera, 38100, Israel|Jerusalem, 91031, Israel|Kfar Saba, 44281, Israel|Nahariya, 22100, Israel|Rehovot, 76100, Israel|Brescia, 25123, Italy|Chieti, 66013, Italy|Ferrara, 44100, Italy|Genova, 16132, Italy|La Spezia, 19124, Italy|Lecco, 23900, Italy|Lodi, 26900, Italy|Palermo, 90127, Italy|Pavia, 27100, Italy|Prato, 50047, Italy|Roma, 00186, Italy|S Fermo Della Battaglia, 22020, Italy|Gdansk, 80-211, Poland|Katowice, 40-027, Poland|Lodz, 90-153, Poland|Radom, 20-610, Poland|Rzeszow, 35-055, Poland|Sieradz, 98-200, Poland|Szczecin, 70-111, Poland|Warszawa, 02-006, Poland|Barcelona, 08025, Spain|Barcelona, 08035, Spain|Barcelona, 08036, Spain|Ciudad Real, 13005, Spain|Hospitalet de Llobregat, 08907, Spain|La Coruna, 15006, Spain|Lerida, 25198, Spain|Madrid, 28007, Spain|Málaga, 29010, Spain|Partida La Ceñuela. Torreviej, 03186, Spain|Belfast, BT9 7LJ, United Kingdom|Birmingham, B15 2TH, United Kingdom|Bradford, BD5 0NA, United Kingdom|Exeter, EX2 5DW, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00442702 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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