Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Hyperphosphatemia Clinical Trial

Official title:

A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771780
• Other study ID #: 7791-007
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2021
• Est. completion date: June 27, 2022

Study information

• Verified date: July 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• KHK7791
oral administration

Locations

Country	Name	City	State
Japan	Medical Corporation Seijinkai Ikeda Hospital	Kanoya	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Dose period Week 1~52
Secondary	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	Week 1~52
Secondary	Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.		Week 1~52
Secondary	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.		Week 1~52
Secondary	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.		Week 1~52
Secondary	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.		Week 1~52
Secondary	Concentration of serum phosphorous levels values at each time point.		Week 1~52
Secondary	Change of serum phosphorous levels from baseline values at each time point.		Week 1~52
Secondary	Achievement/failure of the target serum phosphorus level (serum phosphorus level: = 6.0).		Week 1~52
Secondary	Time when the target serum phosphorus level (serum phosphorus level: = 6.0) was achieved.		Week 1~52
Secondary	Achievement/failure of the target serum phosphorus level (serum phosphorus level: = 5.5).		Week 1~52
Secondary	Time when the target serum phosphorus level (serum phosphorus level: = 5.5) was achieved.		Week 1~52
Secondary	Concentrations of such as Ca × P product levels at each time point.		Week 1~52
Secondary	Changes of such as Ca × P product levels from baseline values at each time point.		Week 1~52