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Clinical Trials/jRCT2031250548
jRCT2031250548RecruitingNot Applicable

A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis

Not provided0 sites100 target enrollmentStarted: TBD
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized

Eligibility Criteria

Ages
18age old over to No limit (—)
Sex
All

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.)

Investigators

Sponsor
Not provided

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