ClinicalTrials.gg
Not yet recruitingNCT07776119Updated Aug 20, 2026

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

An observational study in CKD 5D, Hemodialysis and Hyperphosphatemia Undergoing Hemodialysis, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Peking University People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
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Study 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 are on PBs therapy.

02

Conditions studied

  • CKD 5D, Hemodialysis
  • Hyperphosphatemia Undergoing Hemodialysis

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03

In context

Hyperphosphatemia

173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 25 observational studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemodialysis patients with hyperphosphatemia despite the use of phosphate binders

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject has provided written prior to the initiation of any study-related activities.
  2. Male or female subjects aged ≥18 years at the time of signing the informed consent form.
  3. The subject is receiving regular maintenance hemodialysis (3 times per week, 4 hours per session) for at least 3 months.
  4. The patient has been on phosphate binder therapy for at least 3 weeks, with a stable dose.
  5. Serum phosphorus > 4.5 mg/dL.

Exclusion criteria

Exclusion Criteria:

  1. to Tenapanor or any of the formulation.
  2. 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.
  3. \< 6 months.
  4. Expected or planned kidney transplantation during the study period.
  5. History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).
  6. Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for enrollment.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Tenapanor
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What researchers measure

Primary outcomes

  1. The proportion of patients with serum phosphorus levels <5.5 mg/dL

    Time frame: 3 months

Secondary outcomes

  1. The proportion of patients with serum phosphorus levels <5.5 mg/dL

    Time frame: 1、2、6 months

  2. The proportion of patients achieving the target serum phosphorus level (<4.5 mg/dL)

    Time frame: 1、2、3、6 months

  3. The change from baseline in serum phosphorus levels

    Time frame: 1、2、3、6 months

  4. The dosage and quantity of Tenapanor and phosphate binders used by patients

    Time frame: 1、2、3、6 months

  5. The change from baseline in intact parathyroid hormone (iPTH) levels

    Time frame: 1、2、3、6 months

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Apr 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Apr 10, 2027
CompletionEst.
Oct 10, 2027
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776119
Responsible party
Li Zuo (Director, Department of Nephrology, Peking University People's Hospital; Chief Physician, Professor, Peking University People's Hospital) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Apr 10, 2027 (estimated)
Completion
Oct 10, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Li Zuo
Contact
zuoli@bjmu.edu.cn
+86-13910028495

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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