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

NCT07548853

RecruitingPhase 3

Sponsor: Taisho Pharmaceutical Co., Ltd.

Conditions: Hyperphosphatemia Patients on Peritoneal Dialysis

Interventions: 'TS-172 20~60 mg/day

Countries: Japan

An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.)

Locations (1)

Tokyo, Japan