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Clinical Trial Details

Trial ID: L1631
Source ID: NCT00462384
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Title: A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00462384/results
Conditions: Anemia
Interventions: DRUG: Methoxy Polyethylene Glycol-epoetin Beta
Outcome Measures: Primary: Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP), The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP., Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) | Secondary: Time to Achievement of Response, Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL., Baseline to Week 40|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP, EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented., EEP (Weeks 29 to 36)|Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP, EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented., EEP (Weeks 29 to 36)|Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP, EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period., EEP (Weeks 29 to 36)
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 39
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-02
Completion Date: 2011-04
Results First Posted: 2016-04-01
Last Update Posted: 2016-04-01
Locations: Tallinn, 10617, Estonia|Tallinn, 13419, Estonia|Tartu, 51014, Estonia|HUS, 00029, Finland|Joensuu, 80210, Finland|Jyväskylä, 40620, Finland|Kajaani, 87140, Finland|Kotka, 48210, Finland|Porvoo, 06151, Finland|Tampere, 33521, Finland|Turku, 20521, Finland|Jurmala, LV2015, Latvia|Liepaja, 3402, Latvia|Riga, 1002, Latvia|Riga, LV1038, Latvia|Valmiera, 4201, Latvia|Ventspils, LV 3601, Latvia|Honefoss, 3504, Norway|Lillehammer, 2629, Norway|Oslo, 0407, Norway|Stavanger, 4011, Norway|Trondheim, 7006, Norway
URL: https://clinicaltrials.gov/show/NCT00462384

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress