| Trial ID: | L0902 |
| Source ID: | NCT00536666
|
| Associated Drug: |
Iron Oligosaccharide
|
| Title: |
A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Anemia, Iron-Deficiency
|
| Interventions: |
DRUG: Iron oligosaccharide
|
| Outcome Measures: |
Primary: Adverse events (AE) (Number and type of AE), Eight weeks after enrollment|Serious adverse events (SAEs), Eight weeks after enrollment|Physical examination, At screening visit and at end of study|Vital signs, At every visit|Clinical laboratory tests (biochemistry, haematology), At every visit | Secondary: Change from baseline in haemoglobin, haematocrit, s-iron, transferrin saturation, and ferritin levels, At every visit
|
| Sponsor/Collaborators: |
Sponsor: Pharmacosmos A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
182
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-05
|
| Completion Date: |
2008-08
|
| Results First Posted: |
|
| Last Update Posted: |
2008-10-08
|
| Locations: |
Rigshospitalet, Nefrologisk afdeling P, Copenhagen, DK-2100, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00536666
|
