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CompletedNCT03864458Updated Mar 7, 2024

Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

A Phase 2 interventional study of KHK7791 and Placebo in Hyperphosphatemia, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
207
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study summary

To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.

02

Conditions studied

  • Hyperphosphatemia

Browse trials for

Keywords

  • Tenapanor
  • Hyperphosphatemia
  • Hemodialysis
03

In context

Hyperphosphatemia

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

This study's enrollment of 207 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.

Browse Kyowa Kirin Co., Ltd. studies →

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

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including /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 within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Terms in these criteria, in plain language(3)

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
207 participants (actual)

Study arms

  • Experimental
    KHK7791 A

    Patients take KHK7791 low dose BID.

    Drug: KHK7791

  • Experimental
    KHK7791 B

    Patients take KHK7791 middle dose BID.

    Drug: KHK7791

  • Experimental
    KHK7791 C

    Patients take KHK7791 high dose BID.

    Drug: KHK7791

  • Experimental
    KHK7791 D

    Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question.

    Drug: KHK7791

  • Placebo comparator
    Placebo

    Patients take Placebo BID.

    Drug: Placebo

Interventions

  • DrugKHK7791

    oral administration

  • DrugPlacebo

    oral administration

06

What researchers measure

Primary outcomes

  1. To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.

    Time frame: Week 6

Secondary outcomes

  1. Changes in serum Ca × P levels from baseline.

    Time frame: Week 6

  2. Changes in corrected serum calcium levels from baseline.

    Time frame: Week 6

07

Study locations

1 site
  • Study Site 1
    Nagoya, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Dec 2019, 7 months.

Of 13 phase 2 interventional studies under Hyperphosphatemia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 10. This study's 7 months is close to that.

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

Registered
Mar 4, 2019
First posted
Mar 6, 2019
StartActual
Apr 15, 2019
Primary completionActual
Dec 10, 2019
CompletionActual
Dec 31, 2019
Last update
Mar 7, 2024
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 Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03864458
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Mar 6, 2019
Start date
Apr 15, 2019
Primary completion
Dec 10, 2019
Completion
Dec 31, 2019
Last update
Mar 7, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tenapanor

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