Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Hyperphosphatemia Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767581
• Other study ID #: 7791-004
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: September 2021
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion 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 (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.

5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.

6. Serum phosphorus levels should be in the range of = 3.5 and = 6.0 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.

Exclusion 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.

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• KHK7791
oral administration
• Placebo
oral administration

Locations

Country	Name	City	State
Japan	Kikuchi medical clinic	Tsukuba	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.		Week 8
Secondary	Changes in serum phosphorous levels from baseline values at each time point.		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Achievement/failure of the target serum phosphorus level (serum phosphorus level: = 6.0).		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Time when the target serum phosphorus level (serum phosphorus level: = 6.0) was achieved.		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Achievement/failure of the target serum phosphorus level (serum phosphorus level: = 5.5).		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Time when the target serum phosphorus level (serum phosphorus level: = 5.5) was achieved.		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Concentrations of such as Ca × P product levels at each time point.		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Secondary	Changes of such as Ca × P product levels from baseline values at each time point.		Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.