JPRN-jRCT2031220587
Active, not recruiting
Phase 2
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Mita Seiji0 sites150 target enrollmentJanuary 22, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mita Seiji
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.)
Outcomes
Primary Outcomes
Not specified
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