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

Taisho Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Hyperphosphatemia Patients on Peritoneal Dialysis

Treatments: Drug: 'TS-172 20~60 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT07548853

TS172-03-08

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

'TS-172 20~60 mg/day

Experimental group

Treatment:

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