Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis

NCT ID: NCT04766385

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2021-12-01

Brief Summary

To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between peritoneal dialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.

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 the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.

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 peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.

4. Dialysis conditions, 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 2 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.

Exclusion Criteria

1. Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.

2. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome

3. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.

4. Subjects in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.

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. Having concurrent severe heart disease or hepatic impairment.

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

9. Subjects who have undergone parathyroid intervention within 24 weeks before screening examination., or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study.

10. Uncontrollable hypertension or diabetes.

11. 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.

12. Any diagnosis of and 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

Inoue Hospital

Suita, Osaka, Japan

Countries

Japan

References

Nakayama M, Kobayashi S, Kusakabe M, Ohara M, Nakanishi K, Akizawa T, Fukagawa M. Tenapanor for peritoneal dialysis patients with hyperphosphatemia: a phase 3 trial. Clin Exp Nephrol. 2024 Feb;28(2):153-164. doi: 10.1007/s10157-023-02406-1. Epub 2023 Nov 1.

Reference Type: DERIVED

PMID: 37910313 (View on PubMed)

Other Identifiers

7791-006

Identifier Type: -

Identifier Source: org_study_id