ClinicalTrials.gg
CompletedNCT05699239Updated Feb 28, 2025

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

A Phase 2 interventional study of TS-172 10mg bid and TS-172 30mg bid in Hyperphosphatemia Patients on Hemodialysis, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hyperphosphatemia Patients on Hemodialysis

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03

In context

Hyperphosphatemia

173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.

This study's enrollment of 326 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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)
  2. Patients aged ≥18 to \<80 years at the time of obtaining
  3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

Exclusion criteria

Exclusion Criteria:

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
326 participants (actual)

Study arms

  • Experimental
    10 mg bid

    Patients receive TS-172 10 mg bid.

    Drug: TS-172 10mg bid

  • Experimental
    30 mg bid

    Patients receive TS-172 30 mg bid.

    Drug: TS-172 30mg bid

  • Experimental
    60 mg bid

    Patients receive TS-172 60 mg bid.

    Drug: TS-172 60mg bid

  • Experimental
    20 mg tid

    Patients receive TS-172 20 mg tid.

    Drug: TS-172 20mg tid

  • Placebo comparator
    Placebo

    Patients receive placebo.

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in serum concentration of phosphorus

    Time frame: Week 4

Secondary outcomes

  1. Achievement ratio of patients with the target serum concentration of phosphorus

    Time frame: Up to Week 4

  2. Concentration of corrected serum calcium

    Time frame: Up to Week 4

  3. Serum calcium times phosphorus product

    Time frame: Up to Week 4

07

Study locations

1 site
  • Taisho Pharmaceutical Co., Ltd selected site
    Tokyo, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05699239
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
Feb 8, 2023
Primary completion
Dec 26, 2023
Completion
Dec 26, 2023
Last update
Feb 28, 2025

Study contacts

Taisho Director
study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TS-172

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