| Trial ID: | L0417 |
| Source ID: | NCT00505037
|
| Associated Drug: |
Asp1585
|
| Title: |
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia|Chronic Kidney Disease
|
| Interventions: |
DRUG: ASP1585|DRUG: Placebo|DRUG: Sevelamer hydrochloride
|
| Outcome Measures: |
Primary: Change in serum phosphorus, 4 weeks | Secondary: Change in serum phosphorus level by time, Up to 4 weeks|Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time, 4 Weeks|Change in corrected serum Ca level, 4 weeks|Change in Ca×P, 4 weeks|Change in intact PTH, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
156
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-10
|
| Completion Date: |
2008-09
|
| Results First Posted: |
|
| Last Update Posted: |
2011-03-22
|
| Locations: |
Chubu, Japan|Chugoku, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan|Shikoku, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00505037
|
