Status:
COMPLETED
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
Eligibility Criteria
Inclusion
- Has voluntarily provided written informed consent to participate in the study.
- Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
- Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- 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 ≤ 7.0 mg/dL at screening examination.
- If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
- Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Exclusion
- Peritoneal dialysis was performed within 12 weeks before screening examination.
- 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.
- Subjects who used anti RANKL preparations within 6 weeks before screening examination.
- Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
- Severe heart disease, hepatic impairment, or concurrent cirrhosis.
- Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
- Uncontrollable hypertension or diabetes
- Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT04771780
Start Date
March 15 2021
End Date
June 27 2022
Last Update
August 2 2023
Active Locations (1)
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1
Medical Corporation Seijinkai Ikeda Hospital
Kanoya, Kagoshima-ken, Japan