Back to resultsClinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7791
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring Tenapanor, Hyperphosphatemia, Hemodialysis
Eligibility Criteria
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 (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.
- 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 ≤ 6.0 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 the patients' medical records, etc. before pre-enrollment)
- 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.
- 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.
- Uncontrollable hypertension or diabetes.
- Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period.
- Any diagnosis of and treatment of malignancy within 5 years before screening examination.
Sites / Locations
- Kikuchi medical clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
KHK7791
Placebo
Arm Description
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. 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.
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. 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.
Outcomes
Primary Outcome Measures
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
Secondary Outcome Measures
Changes in serum phosphorous levels from baseline values at each time point.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Concentrations of such as Ca × P product levels at each time point.
Changes of such as Ca × P product levels from baseline values at each time point.
Full Information
NCT ID
NCT04767581
First Posted
February 16, 2021
Last Updated
September 7, 2021
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04767581
Brief Title
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
Tenapanor, Hyperphosphatemia, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7791
Arm Type
Active Comparator
Arm Description
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. 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.
Intervention Type
Drug
Intervention Name(s)
KHK7791
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Changes in serum phosphorous levels from baseline values at each time point.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Concentrations of such as Ca × P product levels at each time point.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Changes of such as Ca × P product levels from baseline values at each time point.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (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.
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 ≤ 6.0 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 the patients' medical records, etc. before pre-enrollment)
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.
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.
Uncontrollable hypertension or diabetes.
Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period.
Any diagnosis of and treatment of malignancy within 5 years before screening examination.
Facility Information:
Facility Name
Kikuchi medical clinic
City
Tsukuba
State/Province
Ibaraki
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
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