jRCT2031250548RecruitingNot Applicable
A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
Not provided0 sites100 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •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 -3)
- •Patients aged >=18 years at the time of obtaining informed consent
- •Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -3)
- •Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3)
Exclusion Criteria
- •Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
- •Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Investigators
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