Hyperphosphatemia Patients on Hemodialysis
Conditions
Brief summary
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Interventions
DRUGTS-172 10mg bid
oral administration of TS-172 10 mg bid
DRUGTS-172 30mg bid
oral administration of TS-172 30 mg bid
DRUGTS-172 60mg bid
oral administration of TS-172 60 mg bid
DRUGTS-172 20mg tid
oral administration of TS-172 20 mg tid
DRUGPlacebo
oral administration of placebo
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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 -4) 2. Patients aged ≥18 to \<80 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)
Exclusion criteria
1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0) 2. Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in serum concentration of phosphorus | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Achievement ratio of patients with the target serum concentration of phosphorus | Up to Week 4 |
| Concentration of corrected serum calcium | Up to Week 4 |
| Serum calcium times phosphorus product | Up to Week 4 |
Countries
Japan
Outcome results
None listed