Clinical Trial Details
| Trial ID: | L1756 |
| Source ID: | NCT00077610 |
| Associated Drug: | Epoetin Alfa Or Beta |
| 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/NCT00077610/results |
| Conditions: | Anemia |
| Interventions: | DRUG: Epoetin alfa or beta|DRUG: RO0503821 (1x/2 Weeks)|DRUG: RO0503821 (1x/4 Weeks) |
| Outcome Measures: | Primary: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period, A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm., Baseline, Week 29 to Week 36 | Secondary: Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration., The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given., Baseline, Week 29 to Week 36|The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods, The number of participants who received RBC transfusions during the titration and evaluation periods were reported ., Week 1 to Week 36|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC), Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10\^9/Litre \[L\], for WBC was 3.0-18.0.0x10\^9/L, and for RBC was 3.80-6.10x10\^12/L., Up to Week 53|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes, Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre \[U/L\]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin \>=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre \[mmol/L\]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L, Up to Week 53|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52, Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD)., Baseline, Week 36 and Week 52|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52, Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline value and a value for specified time period., Baseline, Week 36 and Week 52|Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death, An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported., Upto Week 53 |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 673 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2004-02 |
| Completion Date: | 2005-08 |
| Results First Posted: | 2016-02-29 |
| Last Update Posted: | 2017-01-13 |
| Locations: | Birmingham, Alabama, 35211, United States|Mobile, Alabama, 36608, United States|Montgomery, Alabama, 36106, United States|Encino, California, 91356, United States|Irvine, California, 92868, United States|Los Angeles, California, 90095, United States|Monterey Park, California, 91754, United States|Riverside, California, 92501, United States|Sacramento, California, 95816-5119, United States|San Diego, California, 92103-8342, United States|San Diego, California, 92120, United States|San Francisco, California, 94117, United States|San Jose, California, 95116-1906, United States|Colorado Springs, Colorado, 80909, United States|Denver, Colorado, 80262, United States|Lakewood, Colorado, 80260, United States|Ocala, Florida, 34471, United States|Pembroke Pines, Florida, 33028, United States|Atlanta, Georgia, 30342, United States|Augusta, Georgia, 30901, United States|Chicago, Illinois, 60612, United States|Maywood, Illinois, 60153, United States|Louisville, Kentucky, 40202-1718, United States|Covington, Louisiana, 70433, United States|Boston, Massachusetts, 02115, United States|Boston, Massachusetts, 02215, United States|Springfield, Massachusetts, 01107, United States|Detroit, Michigan, 48202-2689, United States|Brooklyn Center, Minnesota, 55430, United States|Paterson, New Jersey, 07503, United States|Albuquerque, New Mexico, 87131, United States|Bronx, New York, 10467, United States|Brooklyn, New York, 11203, United States|Great Neck, New York, 11021, United States|Mineola, New York, 11501, United States|New York, New York, 10021, United States|New York, New York, 10128, United States|Stony Brook, New York, 11794-8161, United States|Chapel Hill, North Carolina, 27599-7155, United States|Raleigh, North Carolina, 27609, United States|Winston-salem, North Carolina, 27157-1023, United States|Cincinnati, Ohio, 45267-0585, United States|Toledo, Ohio, 43606, United States|Portland, Oregon, 97210, United States|Erie, Pennsylvania, 16502, United States|Philadelphia, Pennsylvania, 19104, United States|Pittsburgh, Pennsylvania, 15224, United States|Pittsburgh, Pennsylvania, 15261, United States|Orangeburg, South Carolina, 29118, United States|Chattanooga, Tennessee, 37404, United States|Nashville, Tennessee, 37205, United States|Nashville, Tennessee, 37232, United States|Austin, Texas, 78705, United States|Houston, Texas, 77054, United States|Houston, Texas, 77099, United States|San Antonio, Texas, 78229, United States|Burlington, Vermont, 05401, United States|Fairfax, Virginia, 22031, United States|Richmond, Virginia, 23298, United States|Marshfield, Wisconsin, 54449, United States|St. John's, Newfoundland and Labrador, A1B 3V6, Canada|Kingston, Ontario, K7L 3N6, Canada|London, Ontario, N6A 5A5, Canada|Mississauga, Ontario, L5M 2V8, Canada|Scarborough, Ontario, M1H 3G4, Canada|Toronto, Ontario, M5G 2C4, Canada|Toronto, Ontario, M9N 1N8, Canada|Montreal, Quebec, H3A 1A1, Canada|Saskatoon, Saskatchewan, S7K 1N4, Canada|Aubervilliers, 93307, France|Bordeaux, 33076, France|La Tronche, 38700, France|Paris, 75 016, France|Paris, 75015, France|Paris, 75651, France|Toulouse, 31059, France|Dortmund, 44263, Germany|Ellwangen, 73479, Germany|München, 80804, Germany|Nürnberg, 90431, Germany|Stuttgart, 70191, Germany|Wiesbaden, 65191, Germany|Wiesloch, 69168, Germany|Como, 22100, Italy|Lecco, 23900, Italy|Lodi, 26900, Italy|Milano, 20162, Italy|Pavia, 27100, Italy|Bergen, 5021, Norway|Levanger, 7600, Norway|Lillehammer, 2629, Norway|Trondheim, 7006, Norway|Barcelona, 08003, Spain|La Coruna, 15006, Spain|Madrid, 28007, Spain|Malaga, 29010, Spain|Sevilla, 41013, Spain|Lausanne, 1003, Switzerland|Lausanne, 1011, Switzerland |
| URL: | https://clinicaltrials.gov/show/NCT00077610 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|