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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003173-40 | EudraCT Number |
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This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Drug | 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) | The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration). | EEP: Weeks 17 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb Concentrations Between EEP and Stability Verification Period (SVP) | Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated. | SVP: Week -4 to Week 0; EEP: Weeks 17 to 28 |
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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 |
|---|---|---|---|---|---|---|
| Barletta | Apulia | 70051 | Italy | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant's hemoglobin (Hb) value. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP | EEP: Weeks 17 to 28 |
| Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP | EEP: Weeks 17 to 28 |
| Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP | The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. | DTP: Weeks 1 to 16; EEP: Weeks 17 to 28 |
| Percentage of Participants Who Required Red Blood Cell Transfusions | Weeks 1 to 28 |
| Molfetta (Ba) |
| Apulia |
| 70056 |
| Italy |
| Putignano | Apulia | 70017 | Italy |
| Caserta | Campania | 81100 | Italy |
| Eboli | Campania | 84025 | Italy |
| Naples | Campania | 80131 | Italy |
| Nola | Campania | 80035 | Italy |
| Solofra | Campania | 83029 | Italy |
| Tivoli | Campania | 00019 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| Albano Laziale | Lazio | 00041 | Italy |
| Civita Castellana | Lazio | 01033 | Italy |
| Viterbo | Lazio | 01100 | Italy |
| Savona | Liguria | 17100 | Italy |
| Cinisello Balsamo | Lombardy | 20092 | Italy |
| Cremona | Lombardy | 26100 | Italy |
| Mantua | Lombardy | 46100 | Italy |
| Monza | Lombardy | 20052 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| S Fermo Della Battaglia | Lombardy | 22020 | Italy |
| Varese | Lombardy | 21100 | Italy |
| Campobasso | Molise | 86100 | Italy |
| Alessandria | Piedmont | 15100 | Italy |
| Chivasso | Piedmont | 10034 | Italy |
| Catania | Sicily | 95124 | Italy |
| Erice | Sicily | 91016 | Italy |
| Messina | Sicily | 98122 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Ancona | The Marches | 60131 | Italy |
| Pesaro | The Marches | 61100 | Italy |
| Lido di Camaiore | Tuscany | 55043 | Italy |
| Pistoia | Tuscany | 51100 | Italy |
| Siena | Tuscany | 53100 | Italy |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who entered the study and received at least one dose of methoxy polyethylene glycol-epoetin beta.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant's Hb value. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) | The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration). | Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP: Weeks 17 to 28 |
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| Secondary | Change in Hb Concentrations Between EEP and Stability Verification Period (SVP) | Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated. | Per protocol population. | Posted | Mean | Standard Deviation | g/dL | SVP: Week -4 to Week 0; EEP: Weeks 17 to 28 |
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| Secondary | Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP | Per protocol population. | Posted | Number | 95% Confidence Interval | percentage of participants | EEP: Weeks 17 to 28 |
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| Secondary | Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP | Per protocol population. | Posted | Median | Full Range | days | EEP: Weeks 17 to 28 |
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| Secondary | Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP | The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. | Per protocol population. | Posted | Number | percentage of participants | DTP: Weeks 1 to 16; EEP: Weeks 17 to 28 |
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| Secondary | Percentage of Participants Who Required Red Blood Cell Transfusions | Safety population. | Posted | Number | percentage of participants | Weeks 1 to 28 |
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36 weeks
Safety population.
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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 | Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant's Hb value. | 10 | 111 | 14 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hospitalisation | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
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| Extremity necrosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal impairment | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | 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 | Hoffman-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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| Participants |
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