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

Sponsor

Taisho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699239

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia Patients on Hemodialysis	Drug: TS-172 10mg bid Drug: TS-172 30mg bid Drug: TS-172 60mg bid Drug: TS-172 20mg tid Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 31, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10 mg bid Patients receive TS-172 10 mg bid.	Drug: TS-172 10mg bid oral administration of TS-172 10 mg bid
Experimental: 30 mg bid Patients receive TS-172 30 mg bid.	Drug: TS-172 30mg bid oral administration of TS-172 30 mg bid
Experimental: 60 mg bid Patients receive TS-172 60 mg bid.	Drug: TS-172 60mg bid oral administration of TS-172 60 mg bid
Experimental: 20 mg tid Patients receive TS-172 20 mg tid.	Drug: TS-172 20mg tid oral administration of TS-172 20 mg tid
Placebo Comparator: Placebo Patients receive placebo.	Drug: Placebo oral administration of placebo

Outcome Measures

Primary Outcome Measures

Change from baseline in serum concentration of phosphorus [Week 4]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Tokyo		Japan

Sponsors and Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taisho Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05699239

Other Study ID Numbers:

TS172-02-01

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperphosphatemia

Study Results

No Results Posted as of Jan 26, 2023