Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
NCT ID: NCT04766398
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
169 participants
INTERVENTIONAL
2021-03-15
2021-09-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KHK7791
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.
KHK7791
oral administration
Placebo
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.
Placebo
oral administration
Interventions
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KHK7791
oral administration
Placebo
oral administration
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
4. Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
7. 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.
8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Exclusion Criteria
2. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
7. Having concurrent severe heart disease or hepatic impairment.
8. Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.
9. Uncontrollable hypertension or diabetes.
10. 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.
11. 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).
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Inoue Hospital
Suita, Osaka, Japan
Countries
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Other Identifiers
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7791-005
Identifier Type: -
Identifier Source: org_study_id