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This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with CKD | This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 | g/dL = grams per deciliter | Months 8 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | g/dL = grams per deciliter | Months 8 to 10 |
| Percentage of Participants With MIRCERA Dose Adjustments |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) initiated on Mircera therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uni Hospital of Alexandroupoli; Nephrology Dept. | Alexandroupoli | 68100 | Greece | |||
| Laiko General Hospital; Nephrology Div. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With CKD | This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated. |
| Up to 10 months |
| Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | An AE 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. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | Up to 10 months |
| Athens |
| 115 27 |
| Greece |
| Red Cross Hospital;Nephrology Dpt. | Athens | 11526 | Greece |
| General Hospital Of Athens G.Gennimatas; Nephrology | Athens | 11527 | Greece |
| Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center | Athens | 11527 | Greece |
| Kyanos Stavros Private Hospital; Nephrologic Clinic | Athens | 11528 | Greece |
| General Hospital Of West Attikis; Nephrology | Athens | 12351 | Greece |
| University Hospital Attikon ; Pathology Clinic | Athens | 124 61 | Greece |
| Nikea General Hospital; Nephrologic Clinic | Athens | 18454 | Greece |
| General Hospital Of Dramas; Dialysis Center Unit | Drama | 66100 | Greece |
| University Hospital Of Heraklion; Nefrologiki Clinic | Heraklion | 71110 | Greece |
| Uni Hospital of Ioannina; Nephrology Dept. | Ioannina | 455 00 | Greece |
| General Hospital Of Katerinis; Nephrology Unit | Katerini | Greece |
| General Hospital of Kilkis; Nephrology | Kilkis | 611 00 | Greece |
| Univeristy Hospital of Larissa; Nephrology | Larissa | 41 110 | Greece |
| Agios Andreas General Hospital; Nephrology | Pátrai | 26335 | Greece |
| Olympion Therapeytirion; Nefrology | Pátrai | 26443 | Greece |
| General Hospital Tzanio ; Nephrology | Piraeus | 18536 | Greece |
| General Hospital Of Serres; Nephrology | Serres | 62100 | Greece |
| AXEPA Pathology Section; A Pathology Clinic | Thessaloniki | 54636 | Greece |
| Thermi Private Clinic; Nephrology | Thessaloniki | 570 01 | Greece |
| Agios Loukas Private Clinic; Nephrology | Thessaloniki | Greece |
| Thessaliki Nossileytiki; Nephrology | Volos | 38221 | Greece |
| General Hospital of Xanthi; Nephrology | Xánthi | Greece |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With CKD | This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. |
| 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 | 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 With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 | g/dL = grams per deciliter | The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. | Posted | Number | percentage of participants | Months 8 to 10 |
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| Secondary | Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | g/dL = grams per deciliter | The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. | Posted | Number | percentage of participants | Months 8 to 10 |
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| Secondary | Percentage of Participants With MIRCERA Dose Adjustments | Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated. | The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. Number analyzed indicates number of participants evaluated at specific time points. | Posted | Number | percentage of participants | Up to 10 months |
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| Secondary | Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | An AE 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. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. | Posted | Count of Participants | Participants | Up to 10 months |
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Up to 10 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 | Participants With CKD | This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. | 56 | 437 | 37 | 437 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Cardiorenal syndrome | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA, 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Death | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA, 19.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| H1N1 influenza | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA, 19.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA, 19.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, 19.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA, 19.1 | Systematic Assessment |
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| Glomerulosclerosis | Renal and urinary disorders | MedDRA, 19.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA, 19.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Haemodialysis | Surgical and medical procedures | MedDRA, 19.1 | Systematic Assessment |
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| Peritoneal dialysis | Surgical and medical procedures | MedDRA, 19.1 | Systematic Assessment |
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| Shock | Vascular disorders | MedDRA, 19.1 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA, 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA, 19.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Catheter site injury | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA, 19.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Testicular abscess | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA, 19.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA, 19.1 | Systematic Assessment |
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| Tendon injury | Injury, poisoning and procedural complications | MedDRA, 19.1 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA, 19.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, 19.1 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA, 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA, 19.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA, 19.1 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA, 19.1 | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA, 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, 19.1 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA, 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA, 19.1 | Systematic Assessment |
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| Haemodialysis | Surgical and medical procedures | MedDRA, 19.1 | Systematic Assessment |
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| Oral surgery | Surgical and medical procedures | MedDRA, 19.1 | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA, 19.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA, 19.1 | Systematic Assessment |
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Study limitations include the absence of a control group and the observational design of the study. In addition, differences between subgroups found in non-interventional studies cannot be used to infer causality.
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 | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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