Treatment for high phosphorus levels in patients on dialysis
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
This study is testing a new medication called TS-172 to see if it can lower high phosphorus levels in adults with kidney disease who are on dialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taisho Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06745531 on ClinicalTrials.gov |
What this trial studies
This phase 3 clinical trial evaluates the efficacy of TS-172, a medication administered at doses of 20 to 60 mg per day, in reducing serum phosphorus levels in patients with hyperphosphatemia undergoing hemodialysis. The study is designed as a randomized, placebo-controlled, double-blind trial, ensuring that neither the participants nor the researchers know who receives the treatment versus the placebo. Eligible participants are adults with chronic kidney disease on hemodialysis who have elevated phosphorus levels. The trial aims to determine if TS-172 can effectively lower these levels compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic kidney disease on hemodialysis who have specific elevated serum phosphorus levels.
Not a fit: Patients with severely elevated phosphorus levels or those who have undergone previous 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 targeting phosphorus control in hemodialysis patients have shown promise, indicating potential for success.
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 -4) 2. Patients aged \>=18 years at the time of obtaining informed consent 3. Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4) 4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL. 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 4 (Week -1) 3. 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.