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Completed

NCT Number: NCT05699239

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

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

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Key information

Conditions

Hyperphosphatemia Patients on Hemodialysis

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.)

Treatment and study plan

TS-172 10mg bid

Drug

oral administration of TS-172 10 mg bid

TS-172 30mg bid

Drug

oral administration of TS-172 30 mg bid

TS-172 60mg bid

Drug

oral administration of TS-172 60 mg bid

TS-172 20mg tid

Drug

oral administration of TS-172 20 mg tid

Placebo

Drug

oral administration of placebo

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

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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