Trial Outcomes & Findings for MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia (NCT NCT00545571)
NCT ID: NCT00545571
Last Updated: 2016-06-24
Results Overview
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
COMPLETED
PHASE3
120 participants
At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
2016-06-24
Participant Flow
Participant milestones
| Measure |
Mircera in Renal Anemia
Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Mircera in Renal Anemia
Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Overall Study
Administrative Reasons
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Refused Treatment
|
1
|
|
Overall Study
Screen Failure
|
16
|
|
Overall Study
Transfusion
|
12
|
|
Overall Study
Early Termination of Study
|
24
|
|
Overall Study
Kidney Transplantation
|
3
|
Baseline Characteristics
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
Mircera in Renal Anemia
n=91 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Age, Continuous
|
67.9 Years
STANDARD_DEVIATION 13.34 • n=99 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24Population: Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol.
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=45 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)
|
75.6 percentage of participants
Interval 60.5 to 87.1
|
SECONDARY outcome
Timeframe: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24Population: ITT Population.
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=91 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Change in Time-Adjusted Hb From Baseline to EEP
|
-0.4 g/dL
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48Population: ITT Population; only participants who entered the LTSP were included in the analysis.
During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=73 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)
|
130 days
Standard Deviation 67.5
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24Population: ITT Population.
During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=91 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP
|
48.4 percentage of participants
Interval 37.7 to 59.1
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48Population: ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.
During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
Outcome measures
| Measure |
Mircera in Renal Anemia
n=51 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Percentage of Hb Values Above or Below the Target Range During the LTSP
Above (n=32)
|
22 percentage of Hb values
|
|
Percentage of Hb Values Above or Below the Target Range During the LTSP
Below (n=51)
|
38 percentage of Hb values
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48Population: ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP or at the last DTP visit were included in the analysis.
During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
Outcome measures
| Measure |
Mircera in Renal Anemia
n=51 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Time Spent Above or Below the Target Range for Hb During the LTSP
Above (n=35)
|
43 days
Standard Deviation 45.3
|
|
Mean Time Spent Above or Below the Target Range for Hb During the LTSP
Below (n=51)
|
48 days
Standard Deviation 41.2
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48Population: ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.
During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as \[Hb value minus country-specific upper bound\] for deviations above the target range and \[Hb value minus country-specific lower bound\] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
Outcome measures
| Measure |
Mircera in Renal Anemia
n=51 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Excursions Above or Below Target Range for Hb During the LTSP
Above (n=32)
|
0.5 g/dL
Standard Deviation 0.42
|
|
Mean Excursions Above or Below Target Range for Hb During the LTSP
Below (n=51)
|
-0.7 g/dL
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48Population: Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not; only those participants (n = number) who provided evaluable data were included in the analysis.
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=90 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
DTP: Any Dose Change (n=90)
|
1.1 months
Standard Deviation 1.11
|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
DTP: Dose Increase (n=90)
|
0.4 months
Standard Deviation 0.75
|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
DTP: Dose Decrease (n=90)
|
0.6 months
Standard Deviation 0.87
|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
LTSP: Any Dose Change (n=67)
|
1.5 months
Standard Deviation 1.32
|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
LTSP: Dose Increase (n=67)
|
0.7 months
Standard Deviation 0.99
|
|
Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
LTSP: Dose Decrease (n=67)
|
0.8 months
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48Population: Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis.
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=91 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Mean Dose of Mircera/CERA During the DTP and LTSP
DTP (n=91)
|
140 mcg
Standard Deviation 48.6
|
|
Mean Dose of Mircera/CERA During the DTP and LTSP
LTSP (n=72)
|
133.8 mcg
Standard Deviation 70.7
|
SECONDARY outcome
Timeframe: From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52Population: ITT Population.
The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=91 Participants
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP
|
15.4 percentage of participants
|
Adverse Events
Mircera in Renal Anemia
Serious adverse events
| Measure |
Mircera in Renal Anemia
n=91 participants at risk
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Angina unstable
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Cardiac failure
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Pleuropericarditis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Cardiac disorders
Right ventricular failure
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Endocrine disorders
Hyperparathyroidism
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Acute abdomen
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
Chest pain
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
Disease progression
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
General physical health deterioration
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
Malaise
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
Pyrexia
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Diverticulitis
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Enterococcal sepsis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Escherichia sepsis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Infection
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Muscle abscess
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Oesophageal candidiasis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Pneumonia
|
3.3%
3/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Subcutaneous abscess
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Urosepsis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
2.2%
2/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Investigations
Haemoglobin decreased
|
4.4%
4/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Metabolism and nutrition disorders
Overweight
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Nervous system disorders
Epilepsy
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Nervous system disorders
Syncope
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Psychiatric disorders
Confusional state
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Social circumstances
Social problem
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Surgical and medical procedures
Catheter placement
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Surgical and medical procedures
Eye operation
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Surgical and medical procedures
Nephrectomy
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Vascular disorders
Haemodynamic instability
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Vascular disorders
Hypertension
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Vascular disorders
Hypotension
|
1.1%
1/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.4%
4/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
Other adverse events
| Measure |
Mircera in Renal Anemia
n=91 participants at risk
Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
5.5%
5/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
5/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
13/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
14/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
7/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
General disorders
Oedema peripheral
|
5.5%
5/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Bronchitis
|
7.7%
7/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
11/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
14/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
5/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
9/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.1%
11/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
5/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
9/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Nervous system disorders
Headache
|
11.0%
10/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
11/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
10/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
6/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
|
Vascular disorders
Hypertension
|
13.2%
12/91 • From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
|
Additional Information
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