A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis

JRCT ID: jRCT2031220587

Registered date:22/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hyperphosphatemia
• Date of first enrollment: 08/02/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Oral drug administration of TS-172 (10 mg bid, 30 mg bid, 60 mg bid or 20 mg tid) for 4 weeks

Outcome(s)

• Primary Outcome: Change from baseline in serum concentration of phosphorus at Week 4

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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)

Exclude 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.)

Related Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT05699239