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This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Renal Anemia Participants | Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol epoetin beta | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) | Visit 2 (Month 1) | |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2) | Visit 3 (Month 2) | |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3) | Visit 4 (Month 3) | |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4) | Visit 5 (Month 4) | |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5) | Visit 6 (Month 5) | |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6) | Visit 7 (Month 6) | |
| Mean Hemoglobin Value at Visit 2 (Month 1) | Visit 2 (Month 1) | |
| Mean Hemoglobin Value at Visit 3 (Month 2) | Visit 3 (Month 2) | |
| Mean Hemoglobin Value at Visit 4 (Month 3) | Visit 4 (Month 3) | |
| Mean Hemoglobin Value at Visit 5 (Month 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study | Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6) | |
| Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glynnwood Hospital | Benoni | 1501 | South Africa | |||
| Universitas Private Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Renal Anemia Participants | Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Visit 5 (Month 4) |
| Mean Hemoglobin Value at Visit 6 (Month 5) | Visit 6 (Month 5) |
| Mean Hemoglobin Value at Visit 7 (Month 6) | Visit 7 (Month 6) |
Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.
| Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7) |
| Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert | Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported. | Up to 6 months |
| Bloemfontein |
| 9301 |
| South Africa |
| GVI Constantiaberg | Cape Town | 7800 | South Africa |
| Groote Schuur Hospital; Renal Unit | Cape Town | 7925 | South Africa |
| N1City Hospital | Cape Town | 7925 | South Africa |
| Dr KB Parag & Raghubir Kidney and Dialysis Centre | Durban | 4001 | South Africa |
| St Augustine Hospital / Chelmsford Medical Center; Nephrology | Durban | South Africa |
| Mayo Clinic | Johannesburg | 1724 | South Africa |
| Sunninghill Hospital | Johannesburg | 2157 | South Africa |
| Donald Gordon Medical Centre | Johannesburg | 2193 | South Africa |
| COMPLETED |
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| NOT COMPLETED |
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Included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Renal Anemia Participants | Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months. |
| 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 |
| |||||||||||||||||||||||
| Diastolic blood pressure (DBP) | Participant's baseline DBP is reported before undergoing hemodialysis as 'DBP pre-dialysis' and after undergoing hemodialysis as 'DBP post-dialysis' and "n" represents the number of participants evaluable for the specified baseline measure. | Mean | Standard Deviation | millimeters of Mercury (mm Hg) |
| |||||||||||||||||||||
| Systolic Blood Pressure (SBP) | Participant's baseline SBP is reported before undergoing hemodialysis as 'SBP pre-dialysis' and after undergoing hemodialysis as 'SBP post-dialysis' and "n" represents the number of participants evaluable for the specified baseline measure. | Mean | Standard Deviation | mm Hg |
| |||||||||||||||||||||
| Pulse rate | The number of participants analyzed for this baseline measure is 65. | Mean | Standard Deviation | beats per minute |
| |||||||||||||||||||||
| Height | The number of participants analyzed for this baseline measure is 86. | Mean | Standard Deviation | centimeters (cm) |
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| Body Weight | The number of participants analyzed for this baseline measure is 97. | Mean | Standard Deviation | kilograms |
| |||||||||||||||||||||
| Number of Participants With Hemoglobin Level Within the Range of 11-12 Grams Per Deciliter (g/dL) | Number | participants |
| |||||||||||||||||||||||
| Mean Hemoglobin Value | Mean | Standard Deviation | g/dL |
| ||||||||||||||||||||||
| Methoxy Polyethylene Glycol-Epoetin Beta Dose | The number of participants analyzed for this baseline measure is 97. | Mean | Standard Deviation | micrograms (mcg) |
|
| 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 | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 2 (Month 1) |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 3 (Month 2) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 4 (Month 3) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 5 (Month 4) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 6 (Month 5) |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Number | participants | Visit 7 (Month 6) |
|
| ||||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 2 (Month 1) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 2 (Month 1) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 3 (Month 2) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 3 (Month 2) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 4 (Month 3) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 4 (Month 3) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 5 (Month 4) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 5 (Month 4) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 6 (Month 5) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 6 (Month 5) |
|
| |||||||||||||||||||||||||||
| Primary | Mean Hemoglobin Value at Visit 7 (Month 6) | Included all enrolled participants who were evaluable for this outcome at the specified timepoint. | Posted | Mean | Standard Deviation | g/dL | Visit 7 (Month 6) |
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| |||||||||||||||||||||||||||
| Secondary | Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study | Included all enrolled participants who were evaluable for this outcome measure and "n" represents number of participants evaluable at the specified time point. | Posted | Mean | Standard Deviation | mcg | Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta | Dose adjustment included dose increase or dose decrease with respect to previous visit's dose. | Included all enrolled participants who were evaluable for this outcome measure. | Posted | Number | participants | Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert | Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported. | Due to observational nature of the study, the data for this outcome measure could not be collected. | Posted | Up to 6 months |
|
|
Up to 6 months
The seriousness of the adverse events was not captured in this observational study, therefore all adverse events are reported as serious adverse events.
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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 | Chronic Renal Anemia Participants | Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months. | 79 | 98 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Arteriovenous fistula thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Transient ischaemic attack | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Vascular access complication | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Catheter placement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Nephrectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| BK virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cholecystitis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Colitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Duodenitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroduodenitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Tuberculosis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Death | General disorders | MedDRA | Non-systematic Assessment |
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| Medical device complication | General disorders | MedDRA | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Renal mass | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Vitamin B1 deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | 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-LaRoche | 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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