Hyperphosphatemia Patients on Peritoneal Dialysis
Conditions
Brief summary
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis
Interventions
DRUG'TS-172 20~60 mg/day
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 peritoneal dialysis (CAPD or APD) at least 12 weeks prior to Visit 1 (Week -4) 2. Patients aged \>= 18 years at the time of obtaining informed consent 3. Patients who are receiving at least one phosphate binder and whose dosing regimen for all phosphate-lowering agents (phosphate binder and tenapanor hydrochloride) has been unchanged during the last 4 weeks prior to Visit 1 (Week -4). 4. Patients with serum phosphorus concentration of \>= 3.5 mg/dL and =\< 7.0 mg/dL at Visit 1 (Week -4) 5. Patients whose serum phosphorus concentration at Visit 2 (Week -2) or Visit 3 (Week -1) or Visit 4 (Week 0) 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 4 (Week 0) 2. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -2) or Visit 3 (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 16 |
| Concentration of corrected serum calcium | Up to Week 16 |
| Serum Ca × P product | Up to Week 16 |
Countries
Japan
Contacts
CONTACTTaisho Pharmaceutical Co., Ltd.
STUDY_DIRECTORTaisho Director
Taisho Pharmaceutical Co., Ltd.
Outcome results
None listed