Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 223
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants on peritoneal dialysis
- •Need for Erythropoiesis Stimulating Agent (ESA) therapy
- •Prescription of methoxy polyethylene glycol epoetin beta by the doctor
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Methoxy polyethylene glycol epoetin beta (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: Month 7 to Month 9
Secondary Outcomes
- 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)