| Trial ID: | L1003 |
| Source ID: | NCT01102413
|
| Associated Drug: |
Monofer
|
| Title: |
Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01102413/results
|
| Conditions: |
Iron Deficiency Anemia|Chronic Kidney Disease
|
| Interventions: |
DRUG: Monofer|DRUG: Iron Sulphate
|
| Outcome Measures: |
Primary: Change in Hemoglobin (Hb) Concentration From Baseline to Week 4., Baseline, 4 weeks | Secondary: Change in Hemoglobin Concentration From Baseline to Week 8, Baseline to week 8
|
| 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: |
2010-04
|
| Completion Date: |
2014-06
|
| Results First Posted: |
2015-12-03
|
| Last Update Posted: |
2015-12-03
|
| Locations: |
Pharmacosmos, Holbaek, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01102413
|
