| Trial ID: | L1266 |
| Source ID: | NCT01222884
|
| Associated Drug: |
Monofer
|
| Title: |
A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01222884/results
|
| Conditions: |
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
|
| Interventions: |
DRUG: Monofer|DRUG: Iron sucrose
|
| Outcome Measures: |
Primary: Ability to Maintain Hemoglobin Level, The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis., Baseline to 6 weeks | Secondary: Change in Hemoglobin Concentration, 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Pharmacosmos A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
351
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-06
|
| Completion Date: |
2013-12
|
| Results First Posted: |
2015-07-24
|
| Last Update Posted: |
2015-12-02
|
| Locations: |
Jatin Kothari, Mumbai, India
|
| URL: |
https://clinicaltrials.gov/show/NCT01222884
|
