CompletedPhase 3

Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Japan213 participantsStarted 2021-03-15

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

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 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 criteria

✕. 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.

What they're measuring

Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.

Timeframe: Dose period Week 1~52

Trial details

NCT IDNCT04771780

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-27

View on ClinicalTrials.gov More Hyperphosphatemia trials