Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter [g/dL] for Switzerland and 10 to 12 g/dL for Austria).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mircera in Renal Anemia | Experimental | Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Time-Adjusted Hb From Baseline to EEP | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bregenz | 6900 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965694 | Derived | Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP) | 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. | 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, 48 |
| Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP | 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. | Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24 |
| Percentage of Hb Values Above or Below the Target Range During the LTSP | 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). | 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, 48 |
| Mean Time Spent Above or Below the Target Range for Hb During the LTSP | 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). | 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, 48 |
| Mean Excursions Above or Below Target Range for Hb During the LTSP | 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). | 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, 48 |
| Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP | 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. | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Mean Dose of Mircera/CERA During the DTP and LTSP | 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. | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP | The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported. | From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52 |
| Feldkirch |
| 6807 |
| Austria |
| Graz | 8020 | Austria |
| Kufstein | 6330 | Austria |
| Linz | 4020 | Austria |
| Salzburg | 5020 | Austria |
| Sankt Pölten | 3100 | Austria |
| Steyr | 4400 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1100 | Austria |
| Vienna | 1130 | Austria |
| Vienna | 1160 | Austria |
| Vienna | 1220 | Austria |
| Basel | 4031 | Switzerland |
| Bellinzona | 6500 | Switzerland |
| Burgdorf | 3400 | Switzerland |
| Geneva | 1205 | Switzerland |
| Lausanne | 1011 | Switzerland |
| Liestal | 4410 | Switzerland |
| Locarno | 6600 | Switzerland |
| Lucerne | 6004 | Switzerland |
| Lugano | 6903 | Switzerland |
| Mendrisio | 6850 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Sion | 1951 | Switzerland |
| Zurich | 8037 | Switzerland |
| Zurich | 8091 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population: All participants who received at least one dose of study drug and for whom data were available from at least one follow-up variable.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mircera in Renal Anemia | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol. | Posted | Number | 95% Confidence Interval | percentage of 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 |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Change in Time-Adjusted Hb From Baseline to EEP | 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. | ITT Population. | Posted | Mean | Standard Deviation | g/dL | 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 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP) | 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. | ITT Population; only participants who entered the LTSP were included in the analysis. | Posted | Mean | Standard Deviation | days | 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, 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Hb Values Above or Below the Target Range During the LTSP | 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). | 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. | Posted | Number | percentage of Hb values | 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, 48 |
| ||||||||||||||||||||||||||||
| Secondary | Mean Time Spent Above or Below the Target Range for Hb During the LTSP | 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). | 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. | Posted | Mean | Standard Deviation | days | 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, 48 |
| |||||||||||||||||||||||||||
| Secondary | Mean Excursions Above or Below Target Range for Hb During the LTSP | 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). | 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. | Posted | Mean | Standard Deviation | g/dL | 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, 48 |
| |||||||||||||||||||||||||||
| Secondary | Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP | 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. | 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. | Posted | Mean | Standard Deviation | months | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
| |||||||||||||||||||||||||||
| Secondary | Mean Dose of Mircera/CERA During the DTP and LTSP | 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. | Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis. | Posted | Mean | Standard Deviation | mcg | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP | The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported. | ITT Population. | Posted | Number | percentage of participants | From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52 |
|
|
From Week -4 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
Safety Population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mircera in Renal Anemia | 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. | 43 | 91 | 62 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Social problem | Social circumstances | MedDRA (12.0) | Non-systematic Assessment |
| |
| Catheter placement | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
The Study was prematurely terminated in Austria as a consequence of Mircera reimbursement denial. However, the Study completed regularly in Switzerland and the overall status of the Study is considered completed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|