HyperphosphatemiaPhase 3NCT04771780
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
A Phase 3 study testing KHK7791 in people with Hyperphosphatemia, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- KHK7791
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteJapan
- Study dates
- 15 Mar 2021to 27 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has voluntarily provided written informed consent to participate in the study.
- Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
- Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
- Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dL at screening examination.
- If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
- Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Who cannot join
- Peritoneal dialysis was performed within 12 weeks before screening examination.
- iPTH > 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
- History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
- History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Subjects who used anti RANKL preparations within 6 weeks before screening examination.
- Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
Show all 12Show fewer
- Severe heart disease, hepatic impairment, or concurrent cirrhosis.
- Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
- Uncontrollable hypertension or diabetes
- Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
- Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
- Any diagnosis of or treatment of malignancy within 5 years before screening examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
- Conditions
- Hyperphosphatemia
- Being tested
- KHK7791
- Keywords
- Tenapanor, Hyperphosphatemia, Hemodialysis
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK7791Drug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| KHK7791 | Experimental | During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test.
KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible. Receives: Drug: KHK7791 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
Measured: Dose period Week 1~52
Secondary outcomes (13)
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.
To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis.
Important secondary endpoint
Measured: Week 1~52
Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Measured: Week 1~52
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.
Measured: Week 1~52
The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Measured: Week 1~52
The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Measured: Week 1~52
Concentration of serum phosphorous levels values at each time point.
Measured: Week 1~52
Change of serum phosphorous levels from baseline values at each time point.
Measured: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Measured: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Measured: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Measured: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Measured: Week 1~52
Concentrations of such as Ca × P product levels at each time point.
Measured: Week 1~52
Changes of such as Ca × P product levels from baseline values at each time point.
Measured: Week 1~52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start15 Mar 2021
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771780
- Sponsor's protocol ID
- 7791-007
- Status last verified
- Jul 2023
- First submitted
- 16 Feb 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Publications
Nagano N, Tokunaga S, Asada S, Fukagawa M, Akizawa T. Tenapanor reduces phosphate binder pill burden among hemodialysis patients in a post hoc phase 3 analysis. Sci Rep. 2026 Jul 1. doi: 10.1038/s41598-026-58594-9. Online ahead of print.
PubMed 42387036Koiwa F, Sato Y, Ohara M, Nakanishi K, Fukagawa M, Akizawa T. Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia. Sci Rep. 2023 Nov 4;13(1):19100. doi: 10.1038/s41598-023-45080-9.
PubMed 37925471
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT04771780
- Acronym / sponsor ID
- 7791-007
- Conditions
- Hyperphosphatemia
- Keywords
- Tenapanor, Hyperphosphatemia, Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 25 Feb 2021 (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.
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHK7791 | Experimental | Drug: KHK7791During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test. KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has voluntarily provided written informed consent to participate in the study.
- Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
- Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
Key exclusion criteria (12 listed)
- Peritoneal dialysis was performed within 12 weeks before screening examination.
- iPTH > 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
- History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
- History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Subjects who used anti RANKL preparations within 6 weeks before screening examination.
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 |
|---|---|---|
| KHK7791oral administration | Drug | KHK7791 |
Primary outcome
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.
Time frame: Dose period Week 1~52
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
13 secondary outcomes
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.
Time frame: Week 1~52
Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.
Time frame: Week 1~52
The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
Concentration of serum phosphorous levels values at each time point.
Time frame: Week 1~52
Change of serum phosphorous levels from baseline values at each time point.
Time frame: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time frame: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time frame: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time frame: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time frame: Week 1~52
Concentrations of such as Ca × P product levels at each time point.
Time frame: Week 1~52
Changes of such as Ca × P product levels from baseline values at each time point.
Time frame: Week 1~52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 42387036Nagano N, Tokunaga S, Asada S, Fukagawa M, Akizawa T. Tenapanor reduces phosphate binder pill burden among hemodialysis patients in a post hoc phase 3 analysis. Sci Rep. 2026 Jul 1. doi: 10.1038/s41598-026-58594-9. Online ahead of print.
- Derived from this study: PubMed 37925471Koiwa F, Sato Y, Ohara M, Nakanishi K, Fukagawa M, Akizawa T. Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia. Sci Rep. 2023 Nov 4;13(1):19100. doi: 10.1038/s41598-023-45080-9.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KHK7791 in people with Hyperphosphatemia, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 2 Aug 2023. 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 Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks. (time frame: Dose period Week 1~52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771780, which also lists 2 linked publications.
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 2 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.