| Trial ID: | L1483 |
| Source ID: | NCT00922610
|
| Associated Drug: |
Methoxy Polyethylene Glycol-Epoetin Beta [Mircera]
|
| Title: |
A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: methoxy polyethylene glycol-epoetin beta [Mircera]
|
| Outcome Measures: |
Primary: Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients, 24 weeks after first dose, through week 25 | Secondary: >=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments, At end of 24 weeks treatment
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
|
| Locations: |
Cavite, 4103, Philippines|Makati City, 1229, Philippines|Manila, 1000, Philippines|Marikina, 1805, Philippines|Pasig City, 1605, Philippines
|
| URL: |
https://clinicaltrials.gov/show/NCT00922610
|
