| Trial ID: | L1085 |
| Source ID: | NCT01213992
|
| Associated Drug: |
Iron Isomaltoside 1000
|
| Title: |
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD
|
| Acronym: |
PK-CKD-03
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Non-dialysis Dependent Chronic Kidney Disease
|
| Interventions: |
DRUG: Iron isomaltoside 1000|DRUG: Iron isomaltoside 1000
|
| Outcome Measures: |
Primary: Total serum iron pharmakokinetic parameters, 30min, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours |
|
| Sponsor/Collaborators: |
Sponsor: Pharmacosmos A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-03
|
| Completion Date: |
2012-11
|
| Results First Posted: |
|
| Last Update Posted: |
2013-11-14
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01213992
|
