| Trial ID: | L1580 |
| Source ID: | NCT01940484
|
| Associated Drug: |
Methoxy Polyethylene Glycol Epoetin Beta
|
| Title: |
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01940484/results
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: Methoxy polyethylene glycol epoetin beta
|
| Outcome Measures: |
Primary: 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), 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) | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
98
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2009-08-31
|
| Completion Date: |
2012-07-31
|
| Results First Posted: |
2016-04-20
|
| Last Update Posted: |
2017-07-05
|
| Locations: |
Glynnwood Hospital, Benoni, 1501, South Africa|Universitas Private Hospital, 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
|
| URL: |
https://clinicaltrials.gov/show/NCT01940484
|
