A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Phase 2
Active, not recruiting
- Conditions
- Hyperphosphatemia
- Registration Number
- JPRN-jRCT2031220587
- Lead Sponsor
- Mita Seiji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
2. Patients aged >=18 to <80 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of >= 3.5 mg/dL and =< 6.0 mg/dL at Visit 1 (Week -4)
Exclusion Criteria
1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration >=10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in serum concentration of phosphorus at Week 4
- Secondary Outcome Measures
Name Time Method