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This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-dialysis, sea level | Active Comparator | Participants received 50-250 mcg SC according to local label. |
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| Dialysis, sea level | Active Comparator | Participants received 50-250 mcg SC according to local label. |
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| Pre-dialysis, >1800 meters | Experimental | Participants received 50-250 mcg SC according to local label. |
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| Dialysis, >1800 meters | Experimental | Participants received 50-250 mcg SC according to local label. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Drug | Participants received 50-250 mcg SC according to local label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL | Up to approximately 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration | From baseline to 6 months | |
| Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment | 3 and 6 months | |
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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 |
|---|---|---|---|---|---|---|
| Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C | Aguascalientes | 20210 | Mexico | |||
87 participants were enrolled in the study. One participant did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-dialysis, Sea Level | Participants received 50-250 mcg subcutaneously (SC) according to local label. |
| FG001 | Dialysis, Sea Level | Participants received 50-250 mcg SC according to local label. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Percentage of Participants With Adverse Events |
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. |
| Up to approximately 20 months |
| Percentage of Participants Requiring Dose Adjustments | This outcome measure was not assessed. | Up to approximately 20 months |
| Incidence of Red Blood Cell Transfusions | This outcome measure was not assessed. | Up to approximately 20 months |
| Nefros Investigación S.C. |
| Delegación Coyoacan |
| CP. 04700 |
| Mexico |
| Centro de hemodialisis del norte S.C. | Mexicali | 21100 | Mexico |
| Hospital Angeles Lindavista;Nefrologia | Mexico City | 07760 | Mexico |
| Hospital Star Medica Morelia | Morelia | 58070 | Mexico |
| Unidad De Dialisis La Loma S.C. | Pureto Vallarta | 48333 | Mexico |
| Hospital Regional De Alta Especialidad De Veracruz; Nephrology | Veracruz | 91700 | Mexico |
| FG002 | Pre-dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. |
| FG003 | Dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-dialysis, Sea Level | Participants received 50-250 mcg SC according to local label. |
| BG001 | Dialysis, Sea Level | Participants received 50-250 mcg SC according to local label. |
| BG002 | Pre-dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. |
| BG003 | Dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. |
| BG004 | Total | Total of all reporting groups |
| 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 | Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL | The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. | Posted | Mean | Standard Deviation | micrograms (mcg) | Up to approximately 20 months |
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| Secondary | Change in Hemoglobin Concentration | The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | From baseline to 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment | The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. | Posted | Number | percentage of participants | 3 and 6 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | The safety population included all enrolled participants who received at least one dose of study drug and had a subsequent safety evaluation dose. | Posted | Number | percentage of participants | Up to approximately 20 months |
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| Secondary | Percentage of Participants Requiring Dose Adjustments | This outcome measure was not assessed. | Data were not collected. | Posted | Up to approximately 20 months |
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| Secondary | Incidence of Red Blood Cell Transfusions | This outcome measure was not assessed. | Data were not collected. | Posted | Up to approximately 20 months |
|
|
Up to approximately 20 months
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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 | Pre-dialysis, Sea Level | Participants received 50-250 mcg SC according to local label. | 1 | 19 | 16 | 19 | ||
| EG001 | Dialysis, Sea Level | Participants received 50-250 mcg SC according to local label. | 3 | 10 | 9 | 10 | ||
| EG002 | Pre-dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. | 2 | 15 | 10 | 15 | ||
| EG003 | Dialysis, >1800 Meters | Participants received 50-250 mcg SC according to local label. | 6 | 42 | 36 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pulmonary oedema | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Collapse cardiovascular | General disorders | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Malignant neoplasm of ampulla of Vater | Hepatobiliary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Infusion site infection | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Cerebral thrombosis | Vascular disorders | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA, Version 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Dyspnoea | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Ventricular hypertrophy | Cardiac disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hyperglycaemia | Endocrine disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hypoglycaemia | Endocrine disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Diabetic retinopathy | Endocrine disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Peptic ulcer | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Catheter related infection | General disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA, Version 10.0 | Systematic Assessment |
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| Infusion site infection | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Chest injury | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | MedDRA, Version 10.0 | Systematic Assessment |
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| Serum ferritin increased | Investigations | MedDRA, Version 10.0 | Systematic Assessment |
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| Transferrin saturation decreased | Investigations | MedDRA, Version 10.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA, Version 10.0 | Systematic Assessment |
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| Blood iron decreased | Investigations | MedDRA, Version 10.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA, Version 10.0 | Systematic Assessment |
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| Oedema peripheral | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Oedema | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Generalised oedema | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Vertigo | Nervous system disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Lipoma of breast | Reproductive system and breast disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Prostatism | Reproductive system and breast disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pharyngotonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pallor | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Eye operation | Surgical and medical procedures | MedDRA, Version 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Ecchymosis | Vascular disorders | MedDRA, Version 10.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA, Version 10.0 | 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 |
| D007674 | Kidney Diseases |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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