An observational study in Hyperphosphatemia and Maintenance Hemodialysis, sponsored by Huashan Hospital. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Huashan Hospital · Observational
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.
This is a single-center, prospective observational study conducted at Huashan Hospital, Fudan University. The study will enroll approximately 70 maintenance hemodialysis (MHD) patients with hyperphosphatemia who meet the inclusion criteria. Patients will be divided into two groups based on their routine care: those receiving Tenapanor and those receiving standard phosphate binders.
All participants will be followed for 8 weeks. The primary endpoint is the change in serum phosphorus levels from baseline to the end of the study. Secondary endpoints include the control rate of hyperphosphatemia, changes in other serum electrolytes and parathyroid hormone levels, as well as the incidence of treatment-related adverse events. Fecal samples will be collected at baseline and week 8 to explore the impact of Tenapanor on intestinal phosphorus metabolism and gut microbiota.
The study aims to provide real-world evidence on the efficacy and safety of Tenapanor in managing hyperphosphatemia in MHD patients, and to investigate its underlying mechanisms related to intestinal metabolism.
152 studies on the registry are indexed under Hyperphosphatemia; 11 are open to participants now.
This study's planned enrollment of 70 is below the median of 148 across 22 observational studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Huashan Hospital is the lead sponsor of 246 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study population includes maintenance hemodialysis patients aged 18-80 years with hyperphosphatemia (serum phosphorus > 1.45 mmol/L) and stable clinical conditions, excluding those with severe gastrointestinal diseases or recent interfering medication use. Approximately 70 eligible patients will be enrolled and divided into Tenapanor and standard phosphate binder groups to observe phosphorus control and related metabolic changes.
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Exclusion Criteria:
Maintenance hemodialysis patients with hyperphosphatemia receiving Tenapanor as part of routine care. Tenapanor is administered orally at doses ranging from 10 mg to 50 mg once or twice daily, titrated according to clinical judgment, for a total study period of 8 weeks.
Drug: Tenapanor
Maintenance hemodialysis patients with hyperphosphatemia receiving standard phosphate binders (e.g., calcium carbonate, lanthanum carbonate, sevelamer) as part of routine care, without Tenapanor use, for a total study period of 8 weeks.
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.
Also known as: Xphozah, Ibsrela
Change in serum phosphorus level
Change in serum phosphorus concentration from baseline to the end of treatment.
Time frame: 8 weeks
Changes in serum calcium
Changes in serum calcium from baseline to week 8.
Time frame: 8 weeks
Changes in serum parathyroid hormone (PTH)
Changes in serum parathyroid hormone (PTH) from baseline to week 8.
Time frame: 8 weeks
Changes of gut microbiota
Changes of gut microbiota detected through metagenomic analysis
Time frame: 8 weeks
Plan to share: Undecided — Data will be made available upon request pending
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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