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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorPeking University People's Hospital

About this trial

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.This real-world study will enroll hemodialysis patients with hyperphosphatemia who are on PBs therapy.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group