A Phase 3 interventional study of KHK7791 in Hyperphosphatemia, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment
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.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 213 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: KHK7791
oral administration
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.
Time frame: Dose period Week 1~52
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
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
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Jun 2022, 15 months.
Of 21 phase 3 interventional studies under Hyperphosphatemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 22. This study's 15 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tenapanor