Clinical Trial Details
| Trial ID: | L1468 |
| Source ID: | NCT01872026 |
| Associated Drug: | Asp7991 |
| Title: | Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy|Pharmacodynamics of ASP7991|Pharmacokinetics of ASP7991 |
| Interventions: | DRUG: ASP7991 |
| Outcome Measures: | Primary: The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination, For 9-16 days after dosing | Secondary: Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F, For 9-16 days after dosing|iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P, For 9-16 days after dosing |
| Sponsor/Collaborators: | Sponsor: Astellas Pharma Inc |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 14 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2012-12-26 |
| Completion Date: | 2013-06-26 |
| Results First Posted: | |
| Last Update Posted: | 2024-11-06 |
| Locations: | Kantou, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01872026 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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