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Clinical trial

A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

ID
Name
TS172-02-01
Description
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Trial arms
Trial start
2023-02-08
Estimated PCD
2023-12-26
Trial end
2023-12-26
Status
Completed
Phase
Early phase I
Treatment
TS-172 10mg bid
oral administration of TS-172 10 mg bid
Arms:
10 mg bid
TS-172 30mg bid
oral administration of TS-172 30 mg bid
Arms:
30 mg bid
TS-172 60mg bid
oral administration of TS-172 60 mg bid
Arms:
60 mg bid
TS-172 20mg tid
oral administration of TS-172 20 mg tid
Arms:
20 mg tid
Placebo
oral administration of placebo
Arms:
Placebo
Size
326
Primary endpoint
Change from baseline in serum concentration of phosphorus
Week 4
Eligibility criteria
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.)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 326, 'type': 'ACTUAL'}}
Updated at
2024-01-17

1 organization

2 products

1 indication

Organization
Taisho Pharmaceutical
Product
TS-172
Indication
Hyperphosphatemia
Product
Placebo