| Trial ID: | L0044 |
| Source ID: | NCT02299661
|
| Associated Drug: |
Ds-1093a
|
| Title: |
Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Disease|Renal Anemia
|
| Interventions: |
DRUG: DS-1093a
|
| Outcome Measures: |
Primary: Plasma concentrations of DS-1093a, Plasma concentrations of DS-1093a and derived PK parameters up to 28 days post-dose., 28 days|Change in serum erythropoietin concentrations, Change in serum erythropoietin concentrations compared to baseline, and derived EPO parameters, up to 6 days post-dose, 6 days | Secondary: Change from baseline for composite haematology parameters, Change from baseline for haematology parameters (reticulocyte count, haemoglobin concentration, haematocrit, red blood cell count) up to 28 days post-dose., 28 days|Change from baseline for composite iron metabolism parameters, Change from baseline for iron metabolism parameters (serum concentrations of iron, transferrin, transferrin saturation, hepcidin-25) up to 7 days post-dose., 7 days|Change from baseline for serum concentrations of vascular endothelial growth factor, Change from baseline for serum concentrations of vascular endothelial growth factor up to 7 days post-dose, 7 days|Number and severity of adverse events, Safety and tolerability up to 28 days post-dose, 28 days
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo | Collaborators: PRA Health Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2014-11
|
| Completion Date: |
2015-05
|
| Results First Posted: |
|
| Last Update Posted: |
2018-12-24
|
| Locations: |
: Hemodialysis Center, Teaching Hospital Hradec Králove, Hradec Kralove, 500 05, Czechia|PRA Clinical Pharmacology Unit, Prague, 170 00 Prague 7, Czechia|PRA Clinical Pharmacology Unit, Budapest, H-1077, Hungary
|
| URL: |
https://clinicaltrials.gov/show/NCT02299661
|
