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

Primary Purpose

Hyperphosphatemia Patients on Hemodialysis

Status

Recruiting

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

TS-172 10mg bid

TS-172 30mg bid

TS-172 60mg bid

TS-172 20mg tid

Placebo

About this trial

This is an interventional treatment trial for Hyperphosphatemia Patients on Hemodialysis

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Taisho Pharmaceutical Co., Ltd selected siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mg bid

30 mg bid

60 mg bid

20 mg tid

Placebo

Arm Description

Patients receive TS-172 10 mg bid.

Patients receive TS-172 30 mg bid.

Patients receive TS-172 60 mg bid.

Patients receive TS-172 20 mg tid.

Patients receive placebo.

Outcomes

Primary Outcome Measures

Change from baseline in serum concentration of phosphorus

Secondary Outcome Measures

Achievement ratio of patients with the target serum concentration of phosphorus

Concentration of corrected serum calcium

Serum calcium times phosphorus product

Full Information

NCT ID

NCT05699239

First Posted

January 12, 2023

Last Updated

February 9, 2023

Sponsor

Taisho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05699239

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2023 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia Patients on Hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

10 mg bid

Arm Type

Experimental

Arm Description

Patients receive TS-172 10 mg bid.

Arm Title

30 mg bid

Arm Type

Experimental

Arm Description

Patients receive TS-172 30 mg bid.

Arm Title

60 mg bid

Arm Type

Experimental

Arm Description

Patients receive TS-172 60 mg bid.

Arm Title

20 mg tid

Arm Type

Experimental

Arm Description

Patients receive TS-172 20 mg tid.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo.

Intervention Type

Drug

Intervention Name(s)

TS-172 10mg bid

Intervention Description

oral administration of TS-172 10 mg bid

Intervention Type

Drug

Intervention Name(s)

TS-172 30mg bid

Intervention Description

oral administration of TS-172 30 mg bid

Intervention Type

Drug

Intervention Name(s)

TS-172 60mg bid

Intervention Description

oral administration of TS-172 60 mg bid

Intervention Type

Drug

Intervention Name(s)

TS-172 20mg tid

Intervention Description

oral administration of TS-172 20 mg tid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral administration of placebo

Primary Outcome Measure Information:

Title

Change from baseline in serum concentration of phosphorus

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Achievement ratio of patients with the target serum concentration of phosphorus

Time Frame

Up to Week 4

Title

Concentration of corrected serum calcium

Time Frame

Up to Week 4

Title

Serum calcium times phosphorus product

Time Frame

Up to Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taisho Pharmaceutical Co., Ltd.

Phone

81-3-3985-1118

clinical-trials_CTG@taisho.co.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taisho Director

Organizational Affiliation

Taisho Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Taisho Pharmaceutical Co., Ltd selected site

City

Tokyo

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taisho Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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