Testing TS-172 for high phosphorus levels in dialysis patients
A Phase 2, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
This study is testing a new medication called TS-172 to see if it can help lower high phosphorus levels in people on hemodialysis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06745518 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the efficacy of TS-172, a phosphate binder, in patients with hyperphosphatemia who are undergoing hemodialysis. The study is designed as a randomized, placebo-controlled, double-blind trial, meaning that neither the participants nor the researchers know who receives the treatment or the placebo. Eligible participants must have been on hemodialysis for at least 12 weeks and have specific serum phosphorus levels. The goal is to determine if TS-172 can effectively lower phosphorus levels compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hyperphosphatemia who are receiving hemodialysis and have been on a stable phosphate binder regimen.
Not a fit: Patients with severely elevated parathyroid hormone levels or those who have had prior parathyroid interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve phosphorus control in patients on hemodialysis, potentially reducing complications associated with hyperphosphatemia.
How similar studies have performed: While this approach is being tested in this specific context, similar studies with phosphate binders have shown promise in managing hyperphosphatemia in dialysis patients.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Tokyo
- Taisho Pharmaceutical Co., Ltd selected site — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Taisho Pharmaceutical Co., Ltd.
- Email: shu_chiken@taisho.co.jp
- Phone: 81-3-3985-1118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.