NCT07548853

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
13mo left

Started Apr 2026

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026May 2027

Study Start

First participant enrolled

April 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Hyperphosphatemia Patients on Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Achievement rate of the target serum phosphorus level

    Week 8

Secondary Outcomes (3)

  • Change from baseline in serum concentration of phosphorus

    Up to Week 16

  • Concentration of corrected serum calcium

    Up to Week 16

  • Serum Ca × P product

    Up to Week 16

Study Arms (1)

'TS-172 20~60 mg/day

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

Interventions

'TS-172 20~60 mg/dayDRUG

oral administration of TS-172 20\~60 mg/day

'TS-172 20~60 mg/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Taisho Director

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Taisho Pharmaceutical Co., Ltd.

CONTACT

81-3-3985-1118shu_chiken@taisho.co.jp

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share