RecruitingPhase 3NCT07548853
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis
An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Peritoneal Dialysis
Sponsor
Taisho Pharmaceutical Co., Ltd.
Enrollment
30 participants
Start Date
Apr 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving peritoneal dialysis (CAPD or APD) at least 12 weeks prior to Visit 1 (Week -4)
- Patients aged >= 18 years at the time of obtaining informed consent
- 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).
- Patients with serum phosphorus concentration of >= 3.5 mg/dL and =< 7.0 mg/dL at Visit 1 (Week -4)
- 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 Criteria3
- Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 4 (Week 0)
- Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (Week -1)
- Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
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Interventions
DRUG'TS-172 20~60 mg/day
oral administration of TS-172 20\~60 mg/day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07548853