| Trial ID: | L1237 |
| Source ID: | NCT02753894
|
| Associated Drug: |
Asp1585
|
| Title: |
Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
|
| Interventions: |
DRUG: ASP1585
|
| Outcome Measures: |
Primary: Change from the baseline of serum phosphorus level, Baseline and Week 6|Safety assessed by AEs, Up to 6 weeks after the study drug dosing|Safety assessed by Hematology test, Up to 6 weeks after the study drug dosing|Safety assessed by Blood biochemistry tests, Up to 6 weeks after the study drug dosing|Safety assessed by Blood cogulability tests, Up to 6 weeks after the study drug dosing|Blood concentration of Vitamin, Up to 6 weeks after the study drug dosing|Safety assessed by Vital signs, Systolic blood pressure, diastolic blood pressure, heart rate, Up to 6 weeks after the study drug dosing|Safety assessed by bowel movement, Up to 6 weeks after the study drug dosing|Safety assessed by ECG, Up to 6 weeks after the study drug dosing | Secondary: Time course of serum phosphorus level, Up to Week 6|Time course of corrected serum calcium level, Up to Week 6|Time course of calcium-phosphorus product, Up to Week 6|Time course of intact parathyroid hormone, Up to Week 6|Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL), Up to Week 6|Time achievement of the target serum phosphorus level (3.5 to 6.0 mg/dL), Up to Week 6
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
73
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2008-06
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-21
|
| Locations: |
Site JP00011, Aichi, Japan|Site JP00009, Chiba, Japan|Site JP00010, Chiba, Japan|Site JP00006, Ibaraki, Japan|Site JP00007, Ibaraki, Japan|Site JP00008, Ibaraki, Japan|Site JP00001, Miyagi, Japan|Site JP00002, Miyagi, Japan|Site JP00003, Nagano, Japan|Site JP00004, Nagano, Japan|Site JP00005, Nagano, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02753894
|
