CompletedNCT04771780Updated Aug 2, 2023

Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

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

Phase: Phase 3
Study type: Interventional
Enrollment: 213
Allocation: Not applicable
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Hyperphosphatemia

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Hyperphosphatemia 148

Keywords

Tenapanor
Hyperphosphatemia
Hemodialysis

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 213 participants (actual)

Study arms

Experimental
KHK7791
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

Interventions

DrugKHK7791
oral administration

What researchers measure

Primary outcomes

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

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.
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

Study locations

1 site

Medical Corporation Seijinkai Ikeda Hospital
Kanoya, Kagoshima, Japan

References and documents

Individual participant data

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.

Registry details

Key details

Study ID: NCT04771780
Lead sponsor: Kyowa Kirin Co., Ltd.
Responsible party: Sponsor
First posted: Feb 25, 2021
Start date: Mar 15, 2021
Primary completion: Jun 27, 2022
Completion: Jun 27, 2022
Last update: Aug 2, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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