Abstract: INFO18-TH
Real-World Effectiveness and Safety of Tenapanor in Patients on Peritoneal Dialysis with Hyperphosphatemia: Rationale and Design of a Prospective Multicenter, Single-Arm, Observational Study
Session Information
- Informational Posters - 1
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- No subcategory defined
Author
- Yu, Xueqing, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Description
Introduction
Hyperphosphatemia is common in peritoneal dialysis (PD) patients and is associated with increased mortality. Many patients fail to achieve target serum phosphorus levels due to intolerance or inadequate response to traditional phosphate binders (PBs). Tenapanor, a gastrointestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor, reduces intestinal phosphate absorption via the paracellular pathway. This study aims to evaluate the real-world effectiveness and safety of tenapanor in PD patients with hyperphosphatemia who have poor response or intolerance to PBs.
Methods
This prospective, multicenter, single-arm observational study will enroll 200 PD adult patients with serum phosphorus >1.45 mmol/L. Key exclusion criteria include chronic diarrhea, active infection, inflammatory bowel disease, or planned kidney transplantation within 12 months. Eligible patients will receive tenapanor 30 mg twice daily, either added to ongoing PBs (for inadequate responders) or replacing PBs (for intolerant patients). Dose adjustments are permitted based on serum phosphorus levels and GI tolerability. The primary endpoint is the proportion of patients achieving serum phosphorus <1.78 mmol/L at 3 months. Secondary endpoints include the change from baseline in serum phosphorus concentration and intact parathyroid hormone (iPTH) level, as well as the proportions of patients achieving serum phosphorus <1.78mmol/L at 6, 9, and 12 months.
Discussion
The phase 3 clinical trial of tenapanor conducted in China have only enrolled hemodialysis patients, leaving a significant evidence gap regarding its efficacy and safety in the PD population. Although previous studies have explored the use of tenapanor in PD patients, they are limited by small sample sizes and short follow-up durations. This real-world study is specifically designed to address these limitations by including a relatively large sample with 12 months of follow-up, thereby providing robust evidence on the long-term effectiveness and safety of tenapanor in PD patients with hyperphosphatemia.