A Phase 3, Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis.

JRCT ID: jRCT2051200144

Registered date:04/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hyperphosphatemia Patients on Hemodialysis
• Date of first enrollment: 15/03/2021
• Target sample size: 140
• Study type: Interventional

Intervention(s)

Hemodialysis patients with hyperphosphatemia who have provided written consent will undergo a screening examination. During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind for 8 weeks. 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.
Concomitant medications (phosphate binders) will be given according to the dosage regimen prescribed for each subject.

Outcome(s)

• Primary Outcome: Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.

Secondary Outcome

- Changes in serum phosphorous levels from baseline values at each time point.
- Achievement of the serum phosphorus level 3.5 mg/dL to <= 6.0 mg/dL at each timepoint and the time of achievement.
- Achievement of the serum phosphorus level 3.5 mg/dL to <= 5.5 mg/dL at each timepoint and the time of achievement.
- Changes in Ca x P product and corrected serum calcium levels from baseline values at each time point.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Has voluntarily provided written informed consent to participate in the study.
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 2 weeks before screening examination.
6) Serum phosphorus levels should be in the range of >= 6.1 and =< 10.0 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.

Exclude criteria

1) Peritoneal dialysis was performed within 12 weeks before screening examination.
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 or cardiovascular 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 during the study period.
11) Any diagnosis of and treatment of malignancy within 5 years before screening examination.
12) Tested positive for HIV or HTLV-1.
13) Expected to develop serious drug allergies, such as anaphylactic shock, or any history of alcohol dependence, illicit drug use, severe mental illness, or drug abuse or addiction within 12 months before screening examination.
14) Not expected to live for >= 12 months.
15) Received other study drugs within 4 weeks before screening examination. However, if there are concerns about the effects on the assessment of efficacy and safety of KHK7791, such as a 5-fold elimination half-life of another investigational product more than 4 weeks, these will be discussed with the sponsor.
16) Has received KHK7791.

Related Information

• Primary Sponsor: Kinoshita Jun
• Secondary ID(s): NCT04766398