A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

NCT05699239 | Completed Phase 2

• 1 other identifier: TS172-02-01
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis

Conditions

Hyperphosphatemia Patients on Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in serum concentration of phosphorus

  Week 4

Secondary Outcomes (3)

• Achievement ratio of patients with the target serum concentration of phosphorus

  Up to Week 4

• Concentration of corrected serum calcium

  Up to Week 4

• Serum calcium times phosphorus product

  Up to Week 4

Study Arms (5)

10 mg bid

EXPERIMENTAL

Patients receive TS-172 10 mg bid.

Drug: TS-172 10mg bid

30 mg bid

EXPERIMENTAL

Patients receive TS-172 30 mg bid.

Drug: TS-172 30mg bid

60 mg bid

EXPERIMENTAL

Patients receive TS-172 60 mg bid.

Drug: TS-172 60mg bid

20 mg tid

EXPERIMENTAL

Patients receive TS-172 20 mg tid.

Drug: TS-172 20mg tid

Placebo

PLACEBO COMPARATOR

Patients receive placebo.

Drug: Placebo

Interventions

TS-172 10mg bid DRUG

oral administration of TS-172 10 mg bid

10 mg bid

TS-172 30mg bid DRUG

oral administration of TS-172 30 mg bid

30 mg bid

TS-172 60mg bid DRUG

oral administration of TS-172 60 mg bid

60 mg bid

TS-172 20mg tid DRUG

oral administration of TS-172 20 mg tid

20 mg tid

Placebo DRUG

oral administration of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
• Patients aged ≥18 to \<80 years at the time of obtaining informed consent
• Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

You may not qualify if:

• Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
• Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
• Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

BID protein, human

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: February 8, 2023
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: February 28, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)