Tenapanor in Maintenance Hemodialysis Patients

NCT07882017 · tracked via the Priya Life Science China tracker

Sponsor

Huashan Hospital

Phase

Observational

Started

2026-09-23

Last updated

2026-10-20

Condition(s) studied

HyperphosphatemiaMaintenance Hemodialysis

Investigational drug(s) / intervention(s)

Tenapanor →

Tenapanor: Tenapanor is an oral sodium-hydrogen exchanger isoform 3 (NHE3) inhibitor, administered at doses of 10-50 mg once or twice daily, titrated per clinical judgment, for the management of hyperphosphatemia in maintenance hemodialysis patients over an 8-week study period.

Study summary

The investigators hypothesize that Tenapanor can improve serum phosphorus control and regulate intestinal metabolism in maintenance hemodialysis patients without increasing the risk of severe gastrointestinal adverse events. Therefore, this study intends to take maintenance hemodialysis patients with hyperphosphatemia as the research object, prospectively observe patients receiving Tenapanor as part of their routine care, and clarify the real-world efficacy of Tenapanor for phosphorus management and its impact on intestinal metabolism in these patients.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Aged 18-80 years with maintenance hemodialysis (MHD) complicated by hyperphosphatemia * Serum phosphorus \> 1.45 mmol/L with inadequate control despite conventional phosphate binders * Stable dietary intake and dialysis prescription with no major adjustments planned within the next 1 month, and able to comply with follow-up visits and sample collection * Provided written informed consent Exclusion Criteria: * Severe liver dysfunction, active enteritis, intestinal tumors, or history of recent colonoscopy or intestinal surgery * Use of antibiotics, proton pump inhibitors (PPIs), laxatives, probiotics, or prebiotics within the past 3 months and unable to discontinue * High risk of intradialytic hypotension or known hypersensitivity to Tenapanor * Participation in other interventional drug trials * Other conditions deemed inappropriate for participation by the investigator

Primary outcome measure(s)

Change in serum phosphorus level — 8 weeks
Change in serum phosphorus concentration from baseline to the end of treatment.

Trial sites (1)

Facility	City	Region	Status
Huashan hospital, Fudan university	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07882017 on ClinicalTrials.gov ↗ ← All trials in China