| Trial ID: | L1615 |
| Source ID: | NCT00317226
|
| Associated Drug: |
Ferric Carboxymaltose (Fcm)
|
| Title: |
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00317226/results
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: Ferric Carboxymaltose (FCM)
|
| Outcome Measures: |
Primary: Incidence of Treatment-emergent Adverse Events, 44 week study duration |
|
| Sponsor/Collaborators: |
Sponsor: American Regent, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
145
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-06
|
| Completion Date: |
2007-09
|
| Results First Posted: |
2015-06-10
|
| Last Update Posted: |
2018-02-20
|
| Locations: |
Luitpold Pharmaceuticals Inc., Norristown, Pennsylvania, 19403, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00317226
|