Clinical Trial Details
| Trial ID: | L0176 |
| Source ID: | NCT03581071 |
| Associated Drug: | Ts-143 |
| Title: | Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients with Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: TS-143 |
| Outcome Measures: | Primary: Incidence of adverse events, To evaluate the safety of TS-143 given single administration in CKD patients by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters., 8 days|Plasma concentrations of unchanged form (ng/mL), The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing., 7 days|Urinary excretions of unchanged form (ng/mL), The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group., 24 hours|Serum EPO concentration, 4 days|Reticulocyte count, 7 days|Plasma vascular endothelial growth factor (VEGF) concentration, 4 days | |
| Sponsor/Collaborators: | Sponsor: Taisho Pharmaceutical Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 29 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2016-10-06 |
| Completion Date: | 2017-07-06 |
| Results First Posted: | |
| Last Update Posted: | 2025-02-28 |
| Locations: | Taisho Pharmaceutical Co., Ltd selected site, Tokyo and other Japanese city, Japan |
| URL: | https://clinicaltrials.gov/show/NCT03581071 |
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