A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia (CARISMA)
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|ClinicalTrials.gov Identifier: NCT00699348|
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia|
|Study Start Date :||July 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Other Name: Mircera
- Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range [ Time Frame: Week 17 up to Week 24 ]Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
- Change in Hemoglobin Concentration Between Reference SVP and EEP [ Time Frame: Week -4 up to Week 0 and Week 17 up to Week 24 ]The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
- Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range [ Time Frame: Week 17 up to Week 24 ]Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
- Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP [ Time Frame: Week 17 up to Week 24 ]Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
- Percentage of Participants Requiring Any Dose Adjustment [ Time Frame: Week 1 up to Week 16 and Week 17 up to Week 24 ]Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
- Number of Participants With Red Blood Cell Transfusion During the Study [ Time Frame: Week -4 up to Week 52 ]Number of participant who underwent red blood cell transfusion during the study was reported.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699348
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|Study Director:||Clinical Trials||Hoffmann-La Roche|