An Open-label Pharmacokinetic Study of TS-172 in Patients on Hemodialysis

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Patients on Hemodialysis

Treatments: Drug: TS-172

Study type: Interventional

Funder types: Industry

Identifiers

NCT06849778

TS172-03-04

Details and patient eligibility

About

A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis

Enrollment: 7 patients

Sex: Male

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

TS-172

Experimental group

Treatment:

Drug: TS-172