Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis (NCT04766385) | Clinical Trial Compass
CompletedPhase 3
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
Japan54 participantsStarted 2021-03-03
Plain-language summary
To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between peritoneal dialysis 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.
✓. Dialysis conditions, 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 2 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.
Exclusion criteria
✕. Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.
✕. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
✕. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
What they're measuring
1
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
. Subjects in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.
✕. 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.
✕. Having concurrent severe heart disease or hepatic impairment.
✕. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.