Clinical trial NCT03831607: A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
Official title: A Phase 2, Open-label Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Keywords: Tenapanor
Hyperphosphatemia
Hemodialysis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.
timeFrame: Week 26
Secondary outcomes:
measure: Serum phosphorus levels at each time point after the start of treatment
timeFrame: up to Week 26
measure: Corrected serum calcium level at each time point after the start of treatment
timeFrame: up to Week 26
Other outcomes:
Locations:
city: Niigata
country: Japan
facility: Study Site 1
Study officials:
References: