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|
|Actual Primary Completion Date :||July 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699348
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|Study Director:||Clinical Trials||Hoffmann-La Roche|