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This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Drug | 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range | The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL. | Weeks 29-36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP) | The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP. | Weeks 0-36 |
| Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP) |
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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 |
|---|---|---|---|---|---|---|
| ASZ Aalst | Aalst | 9300 | Belgium | |||
| ZNA Middelheim |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Weeks 29-36 |
| Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) | Weeks 29-36 |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Weeks 1-40 |
| Antwerp |
| 2020 |
| Belgium |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| AZ Sint Lucas Brugge | Assebroek | 8310 | Belgium |
| CH EpiCURA Site Ath | Ath | 7800 | Belgium |
| CH EpiCURA Site Louis Caty | Baudour | 7331 | Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| Clinique Saint-Jean- Botanique | Brussels | 1000 | Belgium |
| CHU Brugmann (Victor Horta) | Brussels | 1020 | Belgium |
| Clin Univ de Bxl Hôpital Erasme | Brussels | 1070 | Belgium |
| HIS (Joseph Bracops) | Brussels | 1070 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| CHIREC Edith Cavell | Brussels | 1180 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| CHU de Charleroi | Charleroi | 6000 | Belgium |
| AZ Sint Blasius (Dendermonde) | Dendermonde | 9200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| ZOL (Sint Jan) | Genk | 3600 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Ghent | 9000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CH EpiCURA Site Hornu | Hornu | 7301 | Belgium |
| CHR Hutois | Huy | 4500 | Belgium |
| Jan Yperman Onze Lieve Vrouw | Ieper | 8900 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Chr de La Citadelle | Liège | 4000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Clinique Saint-Joseph | Liège | 4000 | Belgium |
| AZ Delta (Campus Wilgenstraat) | Roeselare | 8800 | Belgium |
| AZ Nikolaas (Sint Niklaas) | Sint-Niklaas | 9100 | Belgium |
| CHWapi site IMC | Tournai | 7500 | Belgium |
| AZ Turnhout Sint Jozef | Turnhout | 2300 | Belgium |
| CHR de Verviers - East Belgium | Verviers | 4800 | Belgium |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants who received at least one dose of active drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range | The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL. | Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 29-36 |
|
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| |||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP) | The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP. | ITT population included all participants who entered the titration period and received active drug. | Posted | Mean | Standard Deviation | grams/deciliter (g/dL) | Weeks 0-36 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP) | ITT population included all participants who entered the titration period and received active drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 29-36 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) | ITT population included all participants who entered the titration period and received active drug. | Posted | Mean | Standard Deviation | days | Weeks 29-36 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population included all participants who received at least one dose of active drug. | Posted | Number | percentage of participants | Weeks 1-40 |
|
|
Weeks 1-40
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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 treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) | 15 | 34 | 29 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Administration related reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Medical device complication | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Pseudomembranous colitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Extremity necrosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (13.0) | 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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