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

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hyperphosphatemia Patients on Hemodialysis

Treatments: Drug: TS-172 20mg tid; Drug: TS-172 10mg bid; Drug: TS-172 30mg bid; Drug: Placebo; Drug: TS-172 60mg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05699239

TS172-02-01

Details and patient eligibility

About

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

Enrollment: 326 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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 informed consent
3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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326 participants in 5 patient groups, including a placebo group

10 mg bid

Experimental group

Description:

Patients receive TS-172 10 mg bid.

Treatment:

Drug: TS-172 10mg bid

30 mg bid

Experimental group

Description:

Patients receive TS-172 30 mg bid.

Treatment:

Drug: TS-172 30mg bid

60 mg bid

Experimental group

Description:

Patients receive TS-172 60 mg bid.

Treatment:

Drug: TS-172 60mg bid

20 mg tid

Experimental group

Description:

Patients receive TS-172 20 mg tid.

Treatment:

Drug: TS-172 20mg tid

Placebo

Placebo Comparator group

Description:

Patients receive placebo.

Treatment:

Drug: Placebo