Overview

Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients

Status:
Completed
Trial end date:
2019-12-03
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the effect and safety of KHK7791 in combination with phosphate binders to treat Hyperphosphatemia in ptatients on HD.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyowa Hakko Kirin Co., Ltd
Kyowa Kirin Co., Ltd.
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 2 weeks before screening examination.

- Serum phosphorus levels should be in the range of ≥6.1 and ≤10.0 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).