HyperphosphatemiaNCT07882017
Tenapanor in Maintenance Hemodialysis Patients
An observational study of Hyperphosphatemia and Maintenance Hemodialysis, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperphosphatemia, Maintenance Hemodialysis
- What is being tested?
- Tenapanor
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2026to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
Mengjing Wang, PhD, MD, 021-52889393, fiyona27@126.com
About this study
Official title: Evaluation of the Real-World Efficacy of Tenapanor and Its Effects on Intestinal Metabolism in Patients Undergoing Maintenance Hemodialysis
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.
Read the detailed description
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.
- Conditions
- Hyperphosphatemia, Maintenance Hemodialysis
- Being tested
- Tenapanor
- Keywords
- hyperphosphatemia, MHD
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Also called Xphozah, Ibsrela
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 group | Role | What they receive |
|---|---|---|
| Tenapanor Group | 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. Receives: Drug: Tenapanor | |
| Control Group (Standard Phosphate Binders) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphorus level
Change in serum phosphorus concentration from baseline to the end of treatment.
Measured: 8 weeks
Secondary outcomes (3)
Changes in serum calcium
Changes in serum calcium from baseline to week 8.
Measured: 8 weeks
Changes in serum parathyroid hormone (PTH)
Changes in serum parathyroid hormone (PTH) from baseline to week 8.
Measured: 8 weeks
Changes of gut microbiota
Changes of gut microbiota detected through metagenomic analysis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start23 Sep 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, PhD, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882017
- Sponsor's protocol ID
- KY2026-954
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon request pending
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Real-World Efficacy of Tenapanor and Its Effects on Intestinal Metabolism in Patients Undergoing Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07882017
- Acronym / sponsor ID
- KY2026-954
- Conditions
- Hyperphosphatemia, Maintenance Hemodialysis
- Keywords
- hyperphosphatemia, MHD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenapanor Group | – | Drug: TenapanorMaintenance 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. |
| Control Group (Standard Phosphate Binders) | – | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenapanorAlso: Xphozah, IbsrelaTenapanor 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. | Drug | Tenapanor Group |
Primary outcome
Change in serum phosphorus level
Time frame: 8 weeks
Change in serum phosphorus concentration from baseline to the end of treatment.
3 secondary outcomes
Changes in serum calcium
Time frame: 8 weeks
Changes in serum parathyroid hormone (PTH)
Time frame: 8 weeks
Changes of gut microbiota
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided. Data will be made available upon request pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen, PhD, MD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia and Maintenance Hemodialysis, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengjing Wang, PhD, MD (021-52889393, fiyona27@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum phosphorus level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.