Trial Outcomes & Findings for A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis (NCT NCT00660023)
NCT ID: NCT00660023
Last Updated: 2016-03-15
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 -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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 target range of 10.0 to 12.0 g/dL 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Results posted on
2016-03-15
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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
Treated
|
114
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
29
|
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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
8
|
|
Overall Study
Blood Transfusion
|
5
|
|
Overall Study
Renal Transplantation
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Missed Pregnancy Test
|
1
|
|
Overall Study
Other Screening Failure
|
9
|
Baseline Characteristics
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
Baseline characteristics by cohort
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
|
|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24Population: Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion 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 -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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 target range of 10.0 to 12.0 g/dL 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=88 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
|
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
|
72.7 percentage of participants
Interval 62.2 to 81.7
|
SECONDARY outcome
Timeframe: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 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 -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. 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=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
|
Mean Change in Time-Adjusted Hb From Baseline to EEP
|
-0.06 g/dL
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24Population: ITT Population.
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
|
Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
|
79.0 percentage of participants
Interval 70.3 to 86.0
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24Population: ITT Population.
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL 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=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Time Spent in the Target Range for Hb During the EEP
|
43.5 days
Standard Deviation 15.64
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT Population; the number (n) of participants who received at least one dose during the specific period was used for 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 EEP (Weeks 18 to 24) 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 EEP and expressed in mcg.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
DTP (n=114)
|
113 mcg
Standard Deviation 39.4
|
|
Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
EEP (n=110)
|
100.3 mcg
Standard Deviation 69.43
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT Population; the number (n) of participants who received at least one dose during the specific period was used for 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 EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
DTP (n=114)
|
79.8 percentage of participants
|
|
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
EEP (n=110)
|
48.2 percentage of participants
|
SECONDARY outcome
Timeframe: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24Population: ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.
The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
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Number of Participants Receiving Blood Transfusion During the DTP and EEP
DTP (n=114)
|
3 participants
|
|
Number of Participants Receiving Blood Transfusion During the DTP and EEP
EEP (n=110)
|
0 participants
|
SECONDARY outcome
Timeframe: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24Population: ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.
The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Outcome measures
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
|
|---|---|
|
Number of Blood Transfusions During the DTP and EEP
DTP (n=114)
|
4 blood transfusions
|
|
Number of Blood Transfusions During the DTP and EEP
EEP (n=110)
|
0 blood transfusions
|
Adverse Events
Mircera in Renal Anemia
Serious events: 45 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
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|---|---|
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Nervous system disorders
Cerebral haemorrhage
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Cardiac asthma
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Cardiac failure
|
3.5%
4/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Eye disorders
Cataract
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
General disorders
Medical device complication
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
General disorders
Pyrexia
|
2.6%
3/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Bronchitis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Cellulitis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Device related infection
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Gangrene
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Pneumonia
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Renal cyst infection
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Infections and infestations
Sepsis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Investigations
Haemoglobin decreased
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Nervous system disorders
Headache
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Nervous system disorders
Paraparesis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Surgical and medical procedures
Cataract operation
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Hypertension
|
1.8%
2/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Hypertensive crisis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Intermittent claudication
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Thrombosis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Venous thrombosis
|
0.88%
1/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
Other adverse events
| Measure |
Mircera in Renal Anemia
n=114 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 in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
|
|---|---|
|
Infections and infestations
Bronchitis
|
7.0%
8/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
7.9%
9/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
|
Vascular disorders
Hypertension
|
25.4%
29/114 • Continuously and at every visit from Week -3 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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.
|
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