Hyperphosphatemia
Conditions
Interventions
Oral administration of TS-172 20~60 mg/day for 8 weeks
Sponsors
Seiji Mita
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: '1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week at least 12 weeks prior to Visit 1 (Week -4) 2. Patients aged >= 18 years at the time of obtaining informed consent 3. Patients who are receiving at least one phosphate-lowering agent (phosphate binder and tenapanor hydrochloride) within approved dosage, and whose dosing regimen for all phosphate-lowering agents has been unchanged during the last 4 weeks prior to Visit 1 (Week -4). 4. Patients with serum phosphorus concentration of >= 3.5 mg/dL and = 5.5 mg/dL and < 10.0 mg/dL.
Exclusion criteria
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 4 (Week -1) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of the target serum phosphorus level at Week 8 | — |
Contacts
Public ContactDevelopment Headquarters Management
Taisho Pharmaceutical Co., LTD.
Outcome results
None listed