Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis (NCT04767581) | Clinical Trial Compass
CompletedPhase 3
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Japan165 participantsStarted 2021-03-08
Plain-language summary
To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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 (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.
✓. 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 ≤ 6.0 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 criteria
✕. Peritoneal dialysis was performed within 12 weeks before screening examination.
✕. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
What they're measuring
1
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.