Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

NCT ID: NCT03864458

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-12-31

Brief Summary

To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.

Conditions

Hyperphosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KHK7791 A

Patients take KHK7791 low dose BID.

Group Type: EXPERIMENTAL

KHK7791

Intervention Type: DRUG

oral administration

KHK7791 B

Patients take KHK7791 middle dose BID.

Group Type: EXPERIMENTAL

KHK7791

Intervention Type: DRUG

oral administration

KHK7791 C

Patients take KHK7791 high dose BID.

Group Type: EXPERIMENTAL

KHK7791

Intervention Type: DRUG

oral administration

KHK7791 D

Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question.

Group Type: EXPERIMENTAL

KHK7791

Intervention Type: DRUG

oral administration

Placebo

Patients take Placebo BID.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral administration

Interventions

KHK7791

oral administration

Intervention Type: DRUG

Placebo

oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
• Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
• Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
• Serum phosphorus levels should be in the range of ≥3.5 and ≤6.0 mg/dL at screening examination.
• If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.

Exclusion Criteria

• iPTH >600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
• Having concurrent or a 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.
• Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
• Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as 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 change in the dialysis center (relocate to another hospital/clinic) during the study period.
• Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Study Site 1

Nagoya, , Japan

Countries

Japan

Other Identifiers

7791-001

Identifier Type: -

Identifier Source: org_study_id