Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

NCT ID: NCT04771780

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-06-27

Brief 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

Hyperphosphatemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

KHK7791

Intervention Type: DRUG

oral administration

Interventions

KHK7791

oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has voluntarily provided written informed consent to participate in the study.

2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.

3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.

4. Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.

5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.

6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dL at screening examination.

7. 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.

8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion Criteria

1. Peritoneal dialysis was performed within 12 weeks before screening examination.

2. iPTH > 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)

3. History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome

4. History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.

5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.

6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.

7. Severe heart disease, hepatic impairment, or concurrent cirrhosis.

8. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.

9. Uncontrollable hypertension or diabetes

10. 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.

11. 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.

12. Any diagnosis of or treatment of malignancy within 5 years before screening examination.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Corporation Seijinkai Ikeda Hospital

Kanoya, Kagoshima-ken, Japan

Countries

Japan

References

Koiwa F, Sato Y, Ohara M, Nakanishi K, Fukagawa M, Akizawa T. Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia. Sci Rep. 2023 Nov 4;13(1):19100. doi: 10.1038/s41598-023-45080-9.

Reference Type: DERIVED

PMID: 37925471 (View on PubMed)

Other Identifiers

7791-007

Identifier Type: -

Identifier Source: org_study_id