Trial Outcomes & Findings for A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients. (NCT NCT00546481)

Last Updated: 2016-09-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

Up to Week 24

Results posted on

2016-09-19

Participant Flow

A total of 80 participants were enrolled in this study conducted from 05 November 2007 to 23 December 2009 at 7 centers in Korea.

Participant milestones

Participant milestones
Measure	Correction Phase: CERA Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Correction Phase (CERA or Epoetin Beta) STARTED	39	41	0
Correction Phase (CERA or Epoetin Beta) COMPLETED	33	36	0
Correction Phase (CERA or Epoetin Beta) NOT COMPLETED	6	5	0
Maintenance Phase (CERA) STARTED	0	0	54
Maintenance Phase (CERA) COMPLETED	0	0	50
Maintenance Phase (CERA) NOT COMPLETED	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Correction Phase: CERA Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Correction Phase (CERA or Epoetin Beta) Protocol Violation	1	0	0
Correction Phase (CERA or Epoetin Beta) Withdrawal by Subject	1	3	0
Correction Phase (CERA or Epoetin Beta) Lack of Efficacy	1	0	0
Correction Phase (CERA or Epoetin Beta) Kidney transplantation	2	0	0
Correction Phase (CERA or Epoetin Beta) Lost to Follow-up	1	1	0
Correction Phase (CERA or Epoetin Beta) RBC transfusion	0	1	0
Maintenance Phase (CERA) Withdrawal by Subject	0	0	2
Maintenance Phase (CERA) Kidney transplantation	0	0	1
Maintenance Phase (CERA) Other Reason	0	0	1

Baseline Characteristics

A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Correction Phase: CERA n=39 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=41 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Total n=80 Participants Total of all reporting groups
Age, Continuous	55 Years STANDARD_DEVIATION 15.3 • n=5 Participants	54.3 Years STANDARD_DEVIATION 12.8 • n=7 Participants	54.7 Years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: The Intent-to-Treat population included all randomized participants.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=39 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=41 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24	79.5 Percentage of participants Interval 63.5 to 90.7	87.8 Percentage of participants Interval 73.8 to 95.9	—

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Week 24

Population: The Intent-to-Treat population included all randomized participants.

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

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=39 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=41 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Mean Change From Baseline in Hemoglobin Concentration at Week 24	2.00 Grams per deciliter (g/dL) Standard Deviation 1.51	2.03 Grams per deciliter (g/dL) Standard Deviation 1.37	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: The Intent-to-Treat population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=39 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=41 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24	84 Days Interval 70.0 to 98.0	72 Days Interval 58.0 to 72.0	—

SECONDARY outcome

Timeframe: Up to Week 49

Population: The Intent-to-Treat Population included all randomized participants.

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)

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=39 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=41 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA n=54 Participants Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Number of Participants Who Received Red Blood Cells Transfusions up to Week 49	8 Number of participants	2 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: Up to Week 49

Population: All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. 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.

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.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=38 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=39 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA n=54 Participants Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Number of Participants With Any Adverse Events and Serious Adverse Events Number of participants with any SAE	10 Number of participants	6 Number of participants	8 Number of participants
Number of Participants With Any Adverse Events and Serious Adverse Events Number of participants with any AE	34 Number of participants	39 Number of participants	51 Number of participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Week 24

Population: All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=38 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=39 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 Pre-dialysis: DBP	-1.74 millimeters of mercury Standard Deviation 13.3	3.87 millimeters of mercury Standard Deviation 11.5	—
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 Post-dialysis: SBP	5.26 millimeters of mercury Standard Deviation 22.3	2.59 millimeters of mercury Standard Deviation 23	—
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 Pre-dialysis: SBP	2.74 millimeters of mercury Standard Deviation 22.5	2.72 millimeters of mercury Standard Deviation 19.2	—
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24 Post-dialysis: DBP	0.84 millimeters of mercury Standard Deviation 13.7	3.28 millimeters of mercury Standard Deviation 11.7	—

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Week 24

Population: All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=38 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=39 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24	-5.39 Beats per minute for heart rate Standard Deviation 13.5	-1.79 Beats per minute for heart rate Standard Deviation 10.1	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Correction Phase: CERA n=36 Participants Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.	Correction Phase: Epoetin Beta n=32 Participants Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.	Maintenance Phase: CERA Eligible participants who achieved a hemoglobin target range of level \>=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24	3 Number of participants	3 Number of participants	—

Adverse Events

Correction Phase: CERA

Serious events: 10 serious events

Other events: 34 other events

Deaths: 0 deaths

Correction Phase: Epoetin Beta

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Maintenance Phase: CERA

Serious events: 8 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER