Abstract: INFO16-TH
Rationale and Design of a Real-World Efficacy and Safety Study of Tenapanor Plus Phosphate Binders (PBs) in Chinese Patients on Hemodialysis with Hyperphosphatemia
Session Information
- Informational Posters - 1
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- No subcategory defined
Authors
- Gan, Liangying, Peking University People's Hospital, Beijing, China
- Zuo, Li, Peking University People's Hospital, Beijing, China
Description
Introduction
Hyperphosphatemia, one of the most common complications of end-stage renal disease, is characterized by high prevalence and low control rates among Chinese dialysis patients. In 2025, tenapanor, a sodium hydrogen exchanger 3(NHE3) inhibitor, was approved in China for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis who have an inadequate response or intolerance to phosphate binders (PBs) therapy. However, the efficacy and safety of tenapanor plus PBs in Chinese patients are still unclear. Therefore, we aim to conduct a real-world study to explore the effect of combining two drugs with different mechanisms on hyperphosphatemia management.
Methods
This multicenter, prospective, observational real-world study will enroll 200 hemodialysis patients with hyperphosphatemia who are on PBs therapy. Patients will be enrolled if they meet the following criteria: receiving regular maintenance hemodialysis (3 times per week, 4 hours per session) for at least 3 months; having been on PBs therapy with a stable dose for at least 3 weeks; and having a serum phosphorus > 4.5 mg/dL.
The primary endpoint is the proportion of patients achieving serum phosphorus levels <5.5 mg/dL at 3 months. Secondary endpoints include the proportion of patients achieving the target serum phosphorus level of <5.5 mg/dL at 1, 2, and 6 months; the proportion achieving <4.5 mg/dL at 1, 2, 3, and 6 months; and the change from baseline to 1, 2, 3, and 6 months in serum phosphorus, intact parathyroid hormone (iPTH), and PBs dosage.
Discussion
As the first study in China to evaluate the combination of two phosphate-lowering agents, this trial complements the data from a Chinese phase 3 clinical trial(ChiCTR2300068249, CTR20202588) that was limited to tenapanor monotherapy. Previous studies have confirmed the superior efficacy of tenapanor in combination with PBs, along with an acceptable safety profile. Moreover, this study will further validate the real-world efficacy of tenapanor in Chinese patients.