| Trial ID: | L1669 |
| Source ID: | NCT00548691
|
| Associated Drug: |
Ferric Carboxymaltose
|
| Title: |
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00548691/results
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: Ferric Carboxymaltose|DRUG: Standard Medical Care (SMC)
|
| Outcome Measures: |
Primary: Incidence of Treatment-emergent Serious Adverse Events (SAE's), from Day 0 through 30 days after the last dose of study drug |
|
| Sponsor/Collaborators: |
Sponsor: American Regent, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
513
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-10
|
| Completion Date: |
2009-07
|
| Results First Posted: |
2015-05-13
|
| Last Update Posted: |
2018-02-20
|
| Locations: |
Luitpold Pharmaceuticals, Norristown, Pennsylvania, 19403, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00548691
|
