Patients on Hemodialysis
Conditions
Brief summary
A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis
Interventions
DRUGTS-172
oral administration of TS-172 20 mg
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 74 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of unchanged form in plasma | Day 1, 2, 8 and 9 |
| Concentration of major metabolites in plasma | Day 1, 2, 8 and 9 |
Countries
Japan
Outcome results
None listed