HyperphosphatemiaPhase 3NCT04766398
Phosphate Binder-combination 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 evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination… 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?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 1 siteJapan
- Study dates
- 15 Mar 2021to 27 Sep 2021
- 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 ≤ 6.0 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 the patients' medical records, etc. before pre-enrollment)
- Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- History of gastrectomy or enterectomy 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.
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- Having concurrent severe heart disease or hepatic impairment.
- Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.
- Uncontrollable hypertension or diabetes.
- Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period.
- Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.
- Conditions
- Hyperphosphatemia
- Being tested
- KHK7791, Placebo
- 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
PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| KHK7791 | Active comparator | During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. Receives: Drug: KHK7791 |
| Placebo | Placebo comparator | During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
Measured: Week 8
Secondary outcomes (7)
Changes in serum phosphorous levels from baseline values at each time point.
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Concentrations of such as Ca × P product levels at each time point.
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Changes of such as Ca × P product levels from baseline values at each time point.
Measured: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start15 Mar 2021
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 169 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
- NCT04766398
- Sponsor's protocol ID
- 7791-005
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagano N, Tokunaga S, Asada S, Fukagawa M, Akizawa T. Patient characteristics associated with the need for high doses of tenapanor hydrochloride in dialysis patients with hyperphosphatemia: A pooled analysis of three clinical trials. PLoS One. 2026 Aug 28;21(8):e0356873. doi: 10.1371/journal.pone.0356873. eCollection 2026.
PubMed 42664364
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT04766398
- Acronym / sponsor ID
- 7791-005
- Conditions
- Hyperphosphatemia
- Keywords
- Tenapanor, Hyperphosphatemia, Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 23 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 evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHK7791 | Active comparator | Drug: KHK7791During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. |
| Placebo | Placebo comparator | Drug: PlaceboDuring the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. |
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 (11 listed)
- Peritoneal dialysis was performed within 12 weeks before screening examination.
- iPTH >600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
- Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- History of gastrectomy or enterectomy 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 |
| Placebooral administration | Drug | Placebo |
Primary outcome
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
Time frame: Week 8
7 secondary outcomes
Changes in serum phosphorous levels from baseline values at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Concentrations of such as Ca × P product levels at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Changes of such as Ca × P product levels from baseline values at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
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 28 Oct 2021.
- Derived from this study: PubMed 42664364Nagano N, Tokunaga S, Asada S, Fukagawa M, Akizawa T. Patient characteristics associated with the need for high doses of tenapanor hydrochloride in dialysis patients with hyperphosphatemia: A pooled analysis of three clinical trials. PLoS One. 2026 Aug 28;21(8):e0356873. doi: 10.1371/journal.pone.0356873. eCollection 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. 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 11 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 28 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration. (time frame: Week 8). 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 NCT04766398, which also lists 1 linked publication.
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 28 Oct 2021.