Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritoneal Dialysis participants | Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol epoetin beta | Drug | Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | Month 7 to Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | Month 7 to Month 9 | |
| Average Duration in Days Mircera Was Administered at a Stable Dose | Up to 9 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
N/A
Not provided
Not provided
Not provided
Participants on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w. | Mettmann | 40822 | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Peritoneal Dialysis Participants | Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set (SS) population: Participants who received at least 1 dose of study drug were included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Peritoneal Dialysis Participants | Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 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 |
| 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 Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9). | Posted | Number | percentage of participants | Month 7 to Month 9 |
|
Up to 20 months
Only adverse drug reactions (ADRs) were planned to be reported per protocol for this study and since there were no ADR observed, adverse events were also not observed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peritoneal Dialysis Participants | Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Other Erythropoietin stimulating agent |
|
| Withdrawal by Subject |
|
| Missing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | MES population. | Posted | Number | percentage of participants | Month 7 to Month 9 |
|
|
|
| Secondary | Average Duration in Days Mircera Was Administered at a Stable Dose | MES population. | Posted | Mean | Standard Deviation | days | Up to 9 months |
|
|
|
| 0 |
| 220 |
| 0 |
| 220 |
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |