Hyperphosphatemia Patients on Hemodialysis
Conditions
Brief summary
A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia
Interventions
oral administration of TS-172 20\ 60 mg/day
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 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 -4) 2. Patients aged \>=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4) 4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL.
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 4 (Week -1) 3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of the target serum phosphorus level | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in serum concentration of phosphorus | Up to Week 8 |
| Concentration of corrected serum calcium | Up to Week 8 |
| Serum Ca × P product | Up to Week 8 |
Countries
Japan
Outcome results
None listed