臨床研究等提出・公開システム

A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

A phase 2 study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders

Seiji Mita

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Headquarters Development Management

3-24,1, Takada, Toshima-Ku, Tokyo

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Recruiting

Jan. 13, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

'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 -3)
2. Patients aged >=18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -3)
4. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3)

1. Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Both

Hyperphosphatemia

Oral administration of TS-172 20~60 mg/day for 8 weeks with phosphate binders

Achievement rate of the target serum phosphorus level at Week 8

+81-3-6665-0572

Dec. 06, 2024

No

none