HyperphosphatemiaPhase 2NCT03864458
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients
A Phase 2 study testing KHK7791 in people with Hyperphosphatemia, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- 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
- 207 participants
- Where
- 1 siteJapan
- Study dates
- 15 Apr 2019to 31 Dec 2019
- Phase
- Phase 2
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
- Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- Taking phosphate binders three times per day. 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 or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
Who cannot join
- 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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
- Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) 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 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.
- 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 A | Experimental | Patients take KHK7791 low dose BID. Receives: Drug: KHK7791 |
| KHK7791 B | Experimental | Patients take KHK7791 middle dose BID. Receives: Drug: KHK7791 |
| KHK7791 C | Experimental | Patients take KHK7791 high dose BID. Receives: Drug: KHK7791 |
| KHK7791 D | Experimental | Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question. Receives: Drug: KHK7791 |
| Placebo | Placebo comparator | Patients take Placebo BID. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.
Measured: Week 6
Secondary outcomes (2)
Changes in serum Ca × P levels from baseline.
Measured: Week 6
Changes in corrected serum calcium levels from baseline.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Apr 2019
- Primary completion10 Dec 2019
- Study completion31 Dec 2019
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 207 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
- NCT03864458
- Sponsor's protocol ID
- 7791-001
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT03864458
- Acronym / sponsor ID
- 7791-001
- Conditions
- Hyperphosphatemia
- Keywords
- Tenapanor, Hyperphosphatemia, Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Mar 2019 (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 effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| KHK7791 A | Experimental | Drug: KHK7791Patients take KHK7791 low dose BID. |
| KHK7791 B | Experimental | Drug: KHK7791Patients take KHK7791 middle dose BID. |
| KHK7791 C | Experimental | Drug: KHK7791Patients take KHK7791 high dose BID. |
| KHK7791 D | Experimental | Drug: KHK7791Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question. |
| Placebo | Placebo comparator | Drug: PlaceboPatients take Placebo BID. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
- Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- Taking phosphate binders three times per day. 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 or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
Key exclusion criteria (8 listed)
- 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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
- Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) requiring hospitalization within 6 months 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 A, KHK7791 B, KHK7791 C, KHK7791 D |
| Placebooral administration | Drug | Placebo |
Primary outcome
To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.
Time frame: Week 6
2 secondary outcomes
Changes in serum Ca × P levels from baseline.
Time frame: Week 6
Changes in corrected serum calcium levels from baseline.
Time frame: Week 6
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 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 2 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 5 inclusion and 8 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 7 Mar 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6. (time frame: Week 6). 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 7 Mar 2024.