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This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | 120, 200 or 360 micrograms iv monthly (starting dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average. | Week 17 up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration Between Reference (SVP) and EEP | The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed. | Week -4 up to Week -1 and Week 17 up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | 656 91 | Czechia | ||||
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | C.E.R.A. | Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP |
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed. |
| Week 17 up to Week 24 |
| Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. | Week 17 up to Week 24 |
| Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. | Week 1 to Week 16 and Week 17 to Week 24 |
| Number of Participants With Red Blood Cell Transfusion During the Study | Number of participant who underwent red blood cell transfusion during the study was reported. | Week -4 up to Week 28 |
| Number of Participants With Anti-epoetin Antibody | Week -4 and at early withdrawal or Week 28 |
| Český Krumlov |
| 38127 |
| Czechia |
| Děčín | 405 99 | Czechia |
| Havířov | 736 24 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Jihlava | 586 33 | Czechia |
| Karlovy Vary | 360 73 | Czechia |
| Kolin III | 280 20 | Czechia |
| Liberec | 460 63 | Czechia |
| Nový Jičín | 741 11 | Czechia |
| Olomouc | 775 20 | Czechia |
| Ostrava | 708 52 | Czechia |
| Písek | 397 23 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 14000 | Czechia |
| Prague | 150 30 | Czechia |
| Prague | 169 00 | Czechia |
| Strakonice | 38629 | Czechia |
| Šumperk | 787 01 | Czechia |
| Tábor | 390 03 | Czechia |
| Teplice | 415 01 | Czechia |
| Třebíč | 674 01 | Czechia |
| Ústí nad Labem | 401 13 | Czechia |
| Znojmo | 76275 | Czechia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population was defined as all participants enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | C.E.R.A. | Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks. |
| 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 Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average. | Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
|
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| Secondary | Change in Hemoglobin Concentration Between Reference (SVP) and EEP | The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed. | The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available. | Posted | Mean | Standard Deviation | g/dL | Week -4 up to Week -1 and Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP | Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. | ITT Population. | Posted | Mean | Standard Deviation | days | Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category. | Posted | Number | percentage of participants | Week 1 to Week 16 and Week 17 to Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Red Blood Cell Transfusion During the Study | Number of participant who underwent red blood cell transfusion during the study was reported. | ITT Population. | Posted | Number | participants | Week -4 up to Week 28 |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-epoetin Antibody | ITT Population. | Posted | Number | participants | Week -4 and at early withdrawal or Week 28 |
|
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Up to 28 weeks
Only adverse events with an onset date after the start of medication included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C.E.R.A. | Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks. | 41 | 188 | 38 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Atrioventricular block | 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 |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Coeliac artery stenosis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Intestinal angina | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Accident | 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 |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Graft complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Arteriogram | Investigations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Arteriogram coronary | Investigations | MedDRA 12.0 | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Lung carcinoma cell type unspecified stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Breast dysplasia | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
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| Coronary artery bypass | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
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| Aneurysm ruptured | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Shock | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Week -4 |
| |||||
| Early Withdrawal or Week 28 |
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