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Not yet recruiting Phase 3 NCT07548853

A Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis

Phase 3 – large-scale trial before approval
Conditions: Hyperphosphatemia Patients on Peritoneal Dialysis

Sponsor: Taisho Pharmaceutical Co., Ltd.

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Overview
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis
Who can participate
Inclusion Criteria: 1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving peritoneal dialysis (CAPD or APD) 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 binder and whose dosing regimen for all phosphate-lowering agents (phosphate binder and tenapanor hydrochloride) 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 =\< 7.0 mg/dL at Visit 1 (Week -4) 5. Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL. Exclusion Criteria: 1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 4 (Week 0) 2. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (Week -1) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Interventions
'TS-172 20~60 mg/day
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
31.05.2027
Registry ID
NCT07548853
Source
clinicaltrials.gov
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