CKD 5D, HemodialysisNCT07776119
Real-World Efficacy and Safety of Tenapanor Plus Phosphate Binders in Hemodialysis Patients With Hyperphosphatemia
An observational study of CKD 5D, Hemodialysis and Hyperphosphatemia Undergoing Hemodialysis, run by Peking University People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- CKD 5D, Hemodialysis, Hyperphosphatemia Undergoing Hemodialysis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 10 Oct 2027
- How long will I take part?
- 6 Months
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with hyperphosphatemia despite the use of phosphate binders
Who may be able to join
- 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.
Who cannot join
- 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.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Li Zuo, +86-13910028495, zuoli@bjmu.edu.cn
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tenapanor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with serum phosphorus levels <5.5 mg/dL
Measured: 3 months
Secondary outcomes (5)
The proportion of patients with serum phosphorus levels <5.5 mg/dL
Measured: 1、2、6 months
The proportion of patients achieving the target serum phosphorus level (<4.5 mg/dL)
Measured: 1、2、3、6 months
The change from baseline in serum phosphorus levels
Measured: 1、2、3、6 months
The dosage and quantity of Tenapanor and phosphate binders used by patients
Measured: 1、2、3、6 months
The change from baseline in intact parathyroid hormone (iPTH) levels
Measured: 1、2、3、6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD 5D, HemodialysisStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zuo, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776119
- Sponsor's protocol ID
- 2026PHB376-001
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Efficacy and Safety of Tenapanor Plus Phosphate Binders in Hemodialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT07776119
- Acronym / sponsor ID
- 2026PHB376-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 20 Aug 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenapanor | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with hyperphosphatemia despite the use of phosphate binders
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients with serum phosphorus levels <5.5 mg/dL
Time frame: 3 months
5 secondary outcomes
The proportion of patients with serum phosphorus levels <5.5 mg/dL
Time frame: 1、2、6 months
The proportion of patients achieving the target serum phosphorus level (<4.5 mg/dL)
Time frame: 1、2、3、6 months
The change from baseline in serum phosphorus levels
Time frame: 1、2、3、6 months
The dosage and quantity of Tenapanor and phosphate binders used by patients
Time frame: 1、2、3、6 months
The change from baseline in intact parathyroid hormone (iPTH) levels
Time frame: 1、2、3、6 months
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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
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 CKD 5D, Hemodialysis and Hyperphosphatemia Undergoing Hemodialysis, run by Peking University People's 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 5 inclusion and 6 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 Aug 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 Li Zuo (+86-13910028495, zuoli@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with serum phosphorus levels <5.5 mg/dL (time frame: 3 months). 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 Aug 2026.