Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis

• ClinicalTrials.gov Identifier: NCT04766385
• Recruitment Status: Completed
• First Posted: February 23, 2021
• Last Update Posted: January 11, 2022
• Sponsor: Kyowa Kirin Co., Ltd.
• Information provided by (Responsible Party): Kyowa Kirin Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperphosphatemia	Drug: KHK7791	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Open-label, Single-arm Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
• Actual Study Start Date: March 3, 2021
• Actual Primary Completion Date: December 1, 2021
• Actual Study Completion Date: December 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: KHK7791; oral administration

Outcome Measures

Primary Outcome Measures :

1. Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration. [ Time Frame: Week 8 ]

Secondary Outcome Measures :

1. Changes in serum phosphorous levels from baseline values at each time point. [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
2. Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0). [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
3. Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved. [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
4. Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5). [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
5. Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved. [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
6. Concentrations of such as Ca × P product levels at each time point. [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]
7. Changes of such as Ca × P product levels from baseline values at each time point. [ Time Frame: Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16. ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Inoue Hospital

Suita, Osaka, Japan

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.

More Information

• Responsible Party: Kyowa Kirin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04766385
• Other Study ID Numbers: 7791-006
• First Posted: February 23, 2021
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kyowa Kirin Co., Ltd.:

Tenapanor; Hyperphosphatemia; Peritoneal Dialysis

Additional relevant MeSH terms:

Hyperphosphatemia; Phosphorus Metabolism Disorders; Metabolic Diseases