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This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [C.E.R.A.] | Drug | Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) | The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24. | EEP (Weeks 16 to 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hb Concentration Between SVP and the EEP | The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. | SVP (Week -4 to Week 0) and EEP (Week 16 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 |
|---|---|---|---|---|---|---|
| Twenteborg Ziekenhuis | Almelo | 7609 PP | Netherlands | |||
| Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP |
The EEP was defined as Week 16 to Week 24. |
| EEP (Weeks 16 to 24) |
| Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP | The EEP was defined as Week 16 to Week 24. | EEP (Weeks 16 to 24) |
| Percentage of Participants With Blood Transfusion | Baseline up to Week 28 |
| Percentage of Participants With Dose Adjustment | A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline. | Baseline up to Week 20 |
| Amersfoort |
| 3818 ES |
| Netherlands |
| Bovenij Zkhs; Cardiologie Afd. | Amsterdam | 1034 CS | Netherlands |
| Wilhelmina Ziekenhuis; Inwendige Geneeskunde | Assen | 9401 RK | Netherlands |
| Rode Kruis Ziekenhuis; Inwendige Geneeskunde | Beverwijk | 1942LE | Netherlands |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Reinier De Graaf Groep | Delft | 2625 AD | Netherlands |
| Slingeland Ziekenhuis; Inwendige Geneeskunde | Doetinchem | 7009 BL | Netherlands |
| Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde | Dordrecht | 3318 AT | Netherlands |
| Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde | Drachten | 9202 NN | Netherlands |
| Oosterscheldeziekenhuis | Goes | 4462 RA | Netherlands |
| Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde | Gouda | 2803 HH | Netherlands |
| Atrium Medisch Centrum; Nephrology | Heerlen | 6419 PC | Netherlands |
| Bethesda Hospital; Internal Medicine | Hoogeveen | 7909 | Netherlands |
| Leiden University Medical Center; Nierziekten | Leiden | 2333 ZA | Netherlands |
| Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde | Leiderdorp | 2353 GA | Netherlands |
| Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde | Maastricht | 6229 HX | Netherlands |
| Academisch Ziekenhuis St. Radboud; Nierziekten Afd. | Nijmegen | 6525 GA | Netherlands |
| Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde | Rotterdam | 3015 GD | Netherlands |
| Mc Rijnmond Zuid - Locatie Clara; Infectieziekten | Rotterdam | 3078 HT | Netherlands |
| Ikazia Ziekenhuis; Interne Oncologie | Rotterdam | 3083 AN | Netherlands |
| Zorgsaam Ziekenhuis | Terneuzen | 4535 PA | Netherlands |
| Diakonessenhuis | Utrecht | 3582 KE | Netherlands |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one dose trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels. |
| 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 Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) | The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24. | The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available. | Posted | Number | 95% Confidence Interval | Percentage of participants | EEP (Weeks 16 to 24) |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Change in Hb Concentration Between SVP and the EEP | The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. | ITT population | Posted | Mean | Standard Deviation | g/dL | SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP | The EEP was defined as Week 16 to Week 24. | ITT population | Posted | Number | 95% Confidence Interval | Percentage of participants | EEP (Weeks 16 to 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP | The EEP was defined as Week 16 to Week 24. | ITT population | Posted | Mean | Standard Deviation | Days | EEP (Weeks 16 to 24) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Blood Transfusion | ITT population | Posted | Number | Percentage of participants | Baseline up to Week 28 |
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| Secondary | Percentage of Participants With Dose Adjustment | A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline. | ITT population | Posted | Number | Percentage of participants | Baseline up to Week 20 |
|
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Baseline up to Week 28
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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 | Methoxy Polyethylene Glycol-epoetin Beta | Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels. | 6 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood Potassium increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Renal failure chronic | Renal and urinary 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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| Haemodialysis | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Renal transplant | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Regurgitation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypothermia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood calcium increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood phosphorus increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Speech disorder | 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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| Renal failure chronic | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Haematoma | 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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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-La Roche | 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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