A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD

Hyperphosphatemia Clinical Trial

Official title:

A Phase 2, Open-label Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831607
• Other study ID #: 7791-003
• Status: Completed
• Phase: Phase 2
• Start date: December 27, 2018
• Est. completion date: November 26, 2019

Study information

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

Clinical Trial Summary

To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

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

• Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination.

• Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment.

• Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.

• If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination.

Exclusion Criteria:

• 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.

• Severe heart disease (including congestive heart failure, defined as New York Heart Association [NYHA] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT = 100 U/L before the start of observation period), or concurrent cirrhosis.

• Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination.

• Uncontrollable hypertension or diabetes

• 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 (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• KHK7791
KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets

Locations

Country	Name	City	State
Japan	Study Site 1	Niigata

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	Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.		Week 26
Secondary	Serum phosphorus levels at each time point after the start of treatment		up to Week 26
Secondary	Corrected serum calcium level at each time point after the start of treatment		up to Week 26