A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD (NCT03831607) | Clinical Trial Compass
CompletedPhase 2
A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
Japan67 participantsStarted 2018-12-27
Plain-language summary
To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.
Who can participate
Age range20 Years – 79 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:
* Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
* 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.
* 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.
* Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.
* 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:
* 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.
* 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), hep…
What they're measuring
1
Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.