| Trial ID: | L1607 |
| Source ID: | NCT00576602
|
| Associated Drug: |
Methoxy Polyethylene Glycol-Epoetin Beta [Mircera]
|
| Title: |
A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: methoxy polyethylene glycol-epoetin beta [Mircera]|DRUG: Supportive treatment
|
| Outcome Measures: |
Primary: Change in Hb concentration between baseline and efficacy evaluation period (EEP)., Weeks 13-16 | Secondary: Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions., Throughout study|SF36, Weeks 16 and 48|AEs, laboratory parameters., Throughout study
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-12
|
| Completion Date: |
2008-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-04
|
| Locations: |
Edegem, Belgium|Gent, Belgium|Leuven, Belgium|Amiens, France|Caen, France|Le Kremlin-Bicetre, France|Nice, France|Paris, France|Toulouse, France|Tours, France|Berlin, Germany|Frankfurt AM Main, Germany|Kaiserslautern, Germany|Kiel, Germany|Munchen, Germany|Bari, Italy|Barcelona, Spain|Santander, Spain|Sevilla, Spain|London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00576602
|
