NCT07285291 A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
| NCT ID | NCT07285291 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Taisho Pharmaceutical Co., Ltd. |
| Condition | Hyperphosphatemia Patients on Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2026-12-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2026-01-09 with a primary completion date of 2026-12-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
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 -3) 2. Patients aged \>=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of \>= 5.5 mg/dL and \< 10.0 mg/dL at Visit 1 (Week -3) 4. 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: 1. Patients with confirmed serum intact PTH concentration \> 500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0) 2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Contact & Investigator
Taisho Pharmaceutical Co., Ltd. Taisho Pharmaceutical Co., Ltd.
✉ shu_chiken@taisho.co.jp📞 81-3-3985-1118
Taisho Director Taisho Director
STUDY DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT07285291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperphosphatemia Patients on Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07285291 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT07285291 currently recruiting?
Yes, NCT07285291 is actively recruiting participants. Contact the research team at shu_chiken@taisho.co.jp for enrollment information.
Where is the NCT07285291 trial being conducted?
This trial is being conducted at Tokyo, Japan.
Who is sponsoring the NCT07285291 clinical trial?
NCT07285291 is sponsored by Taisho Pharmaceutical Co., Ltd.. The principal investigator is Taisho Director Taisho Director at Taisho Pharmaceutical Co., Ltd.. The trial plans to enroll 100 participants.