Hyperphosphatemia Patients on Hemodialysis
Conditions
Brief summary
A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.
Interventions
DRUGTS-172
oral administration of TS-172 20\ 60 mg/day
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -2) 2. Patients aged ≥18 years at the time of obtaining informed consent 3. 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 -2) 4. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)
Exclusion criteria
1. Patients with confirmed serum intact PTH concentration \>500 pg/mL at Visit 1 (Week -2) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Up to 26 weeks or up to 52 weeks |
Countries
Japan
Contacts
Primary ContactTaisho Pharmaceutical Co., Ltd.
Outcome results
None listed