Clinical Trial Details
| Trial ID: | L0232 |
| Source ID: | NCT01469078 |
| Associated Drug: | Monofer® |
| Title: | Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: Monofer® |
| Outcome Measures: | Primary: Determination of changes in Iron pharmacokinetic parameters from plasma/serum concentration profile, The follwoing parameter will be determined: AUC0-t, AUC, Cmax, Tmax, Ke, and T1/2, From exposure to 7 days post-exposure | Secondary: Changes in pharmacodynamic parametres, Changes in the following parametres will be determined: Hemoglobin (Hb), Reticulocyte Count, Reticuloycyte Hemoglobin Content (CHr), Ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS), From 0 hours to 4, 8, 24, 48, 72 hours post-exposure and end of study visit|Safety evaluation, The following parameters will be evaluated: Laboratory safety variable, physical examination, vital signs and Electrocardiogram (ECG), From screening to 7 days post-exposure |
| Sponsor/Collaborators: | Sponsor: Pharmacosmos A/S | Collaborators: ClinSmart |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 18 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: |
| Start Date: | 2011-10 |
| Completion Date: | 2012-11 |
| Results First Posted: | |
| Last Update Posted: | 2012-11-08 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT01469078 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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