Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
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|ClinicalTrials.gov Identifier: NCT00517881|
Recruitment Status : Terminated (The study was terminated due to the slow recruitment rate.)
First Posted : August 17, 2007
Results First Posted : May 27, 2016
Last Update Posted : May 27, 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 :||29 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 Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
Other Name: Mircera
- Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin 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 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean 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 17 up to Week 24 ]The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. 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 During EEP [ Time Frame: Week 17 up to Week 24 ]Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
- Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP [ Time Frame: Week 17 up to Week 24 ]Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
- 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.
- Percentage of Participants With Red Blood Cell Transfusion During the Study [ Time Frame: Week 0 up to Week 24 ]Percentage of participant who required red blood cell transfusion during the study was reported.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 0 up to Week 24 ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
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): NCT00517881
|Danderyd, Sweden, 18288|
|Eksjo, Sweden, 57581|
|Eskilstuna, Sweden, 63188|
|Gaevle, Sweden, 80187|
|Goeteborg, Sweden, 41345|
|Gothenburg, Sweden, S-402 76|
|Huddinge, Sweden, 14186|
|Jonkoping, Sweden, 55185|
|Kristianstad, Sweden, 29185|
|Skellefteå, Sweden, S-931 86|
|Stockholm, Sweden, 17176|
|Umea, Sweden, 90185|
|Värnamo, Sweden, 33185|
|Västervik, Sweden, 59381|
|Study Director:||Clinical Trials||Hoffmann-La Roche|