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An open-label pharmacokinetic study of TS-172 in patients on hemodialysis

An open-label pharmacokinetic study of TS-172 in patients on hemodialysis

Mita Seiji

Taisho Pharmaceutical Co., LTD.

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

shu_chiken@taisho.co.jp

Development Headquarters Development Management

Taisho Pharmaceutical Co., LTD.

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

+81-3-3985-1118

shu_chiken@taisho.co.jp

Not Recruiting

Mar. 17, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
(2) Patients aged >= 18 and < 75 years at the time of obtaining informed consent

(1) Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
(2) Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
(3) Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)

Male

Hyperphosphatemia

TS-172 20 mg orally as a single dose just before meals

- Concentration of unchanged form and its major metabolites in plasma
- Pharmacokinetic parameters in plasma

+81-3-3881-6116

Feb. 28, 2025

No

none