A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
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|ClinicalTrials.gov Identifier: NCT00546481|
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : July 18, 2016
Last Update Posted : September 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] Drug: Epoetin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: Correction Phase: CERA||
Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
0.6 micrograms/kg every 2 weeks
|Active Comparator: Correction Phase: Epoetin Beta||
As prescribed, iv, 3 times weekly
- Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 [ Time Frame: Up to Week 24 ]Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented
- Mean Change From Baseline in Hemoglobin Concentration at Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ]Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value
- Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24 [ Time Frame: Up to Week 24 ]Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.
- Number of Participants Who Received Red Blood Cells Transfusions up to Week 49 [ Time Frame: Up to Week 49 ]The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)
- Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 49 ]An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
- Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ]Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
- Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24 [ Time Frame: From Baseline (Day 1) to Week 24 ]Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
- Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24 [ Time Frame: Up to Week 24 ]Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
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): NCT00546481
|Korea, Republic of|
|Gyeonggi-do, Korea, Republic of, 431-070|
|Seoul, Korea, Republic of, 110-744|
|Seoul, Korea, Republic of, 134-701|
|Seoul, Korea, Republic of, 135-710|
|Seoul, Korea, Republic of, 137-701|
|Seoul, Korea, Republic of, 405-760|
|Sungnam, Korea, Republic of, 463-802|
|Study Director:||Clinical Trials||Hoffmann-La Roche|