Real-World Efficacy and Safety of Tenapanor Plus Phosphate Binders in Hemodialysis Patients With Hyperphosphatemia

Inclusion criteria

• The subject has provided written informed consent prior to the initiation of any study-related activities.
• Male or female subjects aged ≥18 years at the time of signing the informed consent form.
• The subject is receiving regular maintenance hemodialysis (3 times per week, 4 hours per session) for at least 3 months.
• The patient has been on phosphate binder therapy for at least 3 weeks, with a stable dose.
• Serum phosphorus > 4.5 mg/dL.

Exclusion criteria

• Hypersensitivity to Tenapanor or any excipients of the formulation.
• History of diarrhea within 1 week prior to the start of treatment. Diarrhea is defined as a Bristol Stool Form Scale (BSFS) score ≥6 (i.e., mushy or liquid stools with no solid pieces), a daily bowel movement frequency ≥3 times, and a duration of ≥2 days.
• Life expectancy < 6 months.
• Expected or planned kidney transplantation during the study period.
• History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).
• Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for enrollment.