Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005799-15 | EudraCT Number |
Not provided
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This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C.E.R.A. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) | Drug | Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. 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 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 0) and the value during EEP (Week 17 up to Week 24) was assessed. | Week -4 up to Week 0 and Week 17 up to Week 24 |
| Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range |
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 |
|---|---|---|---|---|---|---|
| Acireale | 95024 | Italy | ||||
| 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. | |
| 24052462 | Derived |
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Not provided
Not provided
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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 [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Median time spent by participants with hemoglobin concentration within 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 any 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 up to Week 16 and Week 17 up 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 52 |
| Ancona |
| 60121 |
| Italy |
| Anzio | 00042 | Italy |
| Arenzano | 16011 | Italy |
| Ascoli Piceno | 63100 | Italy |
| Avellino | 83100 | Italy |
| Benevento | 82100 | Italy |
| Bollate | 20021 | Italy |
| Borgomanero | 28021 | Italy |
| Brescia | 25123 | Italy |
| Brindisi | 72100 | Italy |
| Cagliari | 09100 | Italy |
| Castellammare di Stabia | 80053 | Italy |
| Catania | 95124 | Italy |
| Catania | 95126 | Italy |
| Cernusco sul Naviglio | 20063 | Italy |
| Chieri | 10023 | Italy |
| Chieti | 66013 | Italy |
| Civitavecchia | 00053 | Italy |
| Cosenza | 87100 | Italy |
| Ferrara | 44100 | Italy |
| Florence | 50011 | Italy |
| Florence | 50100 | Italy |
| Foggia | 71100 | Italy |
| Genova | 16132 | Italy |
| La Spezia | 19124 | Italy |
| Lecco | 23900 | Italy |
| Legnano | 20025 | Italy |
| Lido di Ostia | 00121 | Italy |
| Lodi | 26900 | Italy |
| Lucera | 71036 | Italy |
| Mantua | 46100 | Italy |
| Matera | 75100 | Italy |
| Milan | 20142 | Italy |
| Milazzo | 98057 | Italy |
| Montevarchi | 52025 | Italy |
| Naples | 80131 | Italy |
| Naples | 80137 | Italy |
| Nocera Inferiore | 84014 | Italy |
| Novara | 28100 | Italy |
| Nuoro | 08100 | Italy |
| Palermo | 90127 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06126 | Italy |
| Piacenza | 29100 | Italy |
| Pisa | 56100 | Italy |
| Ravenna | 48100 | Italy |
| Reggio Emilia | 42100 | Italy |
| Roma | 00133 | Italy |
| Roma | 00149 | Italy |
| Roma | 00161 | Italy |
| Roma | 00189 | Italy |
| San Daniele del Friuli | 33038 | Italy |
| San Miniato | 56028 | Italy |
| Sassari | 07100 | Italy |
| Taranto | 74100 | Italy |
| Torino | 10126 | Italy |
| Udine | 33100 | Italy |
| Verona | 37126 | Italy |
| Vicenza | 36100 | Italy |
| Locatelli F, Mandolfo S, Menegato Adorati M, Villa G, Tarchini R, Pizzarelli F, Conte F, Guastoni C, Ricciardi B, Crotta A. Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia. J Nephrol. 2013 Nov-Dec;26(6):1114-21. doi: 10.5301/jn.5000251. Epub 2013 Sep 13. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population included all participants who were treated with at least 1 dose of C.E.R.A. and had a safety follow-up, whether withdrawn prematurely or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. 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 to Week 24) was estimated as a time adjusted average. | Per protocol (PP) population included all participants who received at least 1 dose of C.E.R.A. and for whom data for at least 1 follow-up variable was available with the exception of participants who did not fulfill the protocol specified inclusion criteria for this analysis set. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
|
|
| |||||||||||||||||||||||||
| 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 0) and the value during EEP (Week 17 up to Week 24) was assessed. | PP Population. | Posted | Mean | Standard Deviation | g/dL | Week -4 up to Week 0 and Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range | 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. | PP population. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. | PP population. | Posted | Median | Full Range | days | Week 17 up to Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring any 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. | PP population. | Posted | Number | percentage of participants | Week 1 up to Week 16 and Week 17 up 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. | Safety population. | Posted | Number | participants | Week -4 up to Week 52 |
|
|
Up to 52 weeks
Only adverse events with an onset date after the start of medication were included.
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 | 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 C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks. | 98 | 351 | 23 | 351 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Campylobacter intestinal infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oropharyngitis fungal | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Necrosis ischaemic | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
|
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
|
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