Recruiting NCT07285291
A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TS-172 20~60 mg/day, Placebo.
- Who it may be relevant to
- Registry conditions: Hyperphosphatemia Patients on Hemodialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Overview
A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
Interventions
- Drug TS-172 20~60 mg/day
oral administration of TS-172 20\~60 mg/day - Drug Placebo
oral administration of placebo
Primary outcome measures
- Achievement rate of the target serum phosphorus level [Time frame: Week 8]
Secondary outcome measures (3)
- Change from baseline in serum concentration of phosphorus [Time frame: Up to Week 8]
- Concentration of corrected serum calcium [Time frame: Up to Week 8]
- Serum Ca × P product [Time frame: Up to Week 8]
Eligibility criteria
Inclusion criteria
- 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 -3)
- Patients aged >=18 years at the time of obtaining informed consent
- Patients with a serum phosphorus concentration of >= 5.5 mg/dL and < 10.0 mg/dL at Visit 1 (Week -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 -3)
Exclusion criteria
- Patients with confirmed serum intact PTH concentration > 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
- Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Taisho Pharmaceutical Co., Ltd selected site — Tokyo
Identifiers
NCT: NCT07285291 · TS172-03-02