A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
Study Details
Study Description
Brief Summary
To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KHK7791 Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question. |
Drug: KHK7791
KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline. [Week 26]
Secondary Outcome Measures
- Serum phosphorus levels at each time point after the start of treatment [up to Week 26]
- Corrected serum calcium level at each time point after the start of treatment [up to Week 26]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
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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.
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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.
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Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.
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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:
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iPTH > 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
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History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
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History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
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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.
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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.
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Uncontrollable hypertension or diabetes
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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.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Study Site 1 | Niigata | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7791-003