Back to resultsPhosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7791
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 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.
- Uncontrollable hypertension or diabetes
- Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
- Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
- Any diagnosis of or treatment of malignancy within 5 years before screening examination.
Sites / Locations
- Medical Corporation Seijinkai Ikeda Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7791
Arm Description
During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test. KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible.
Outcomes
Primary Outcome Measures
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.
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.
Secondary Outcome Measures
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.
To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis.
Important secondary endpoint
Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.
The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Concentration of serum phosphorous levels values at each time point.
Change of 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
1. Study Identification
Unique Protocol Identification Number
NCT04771780
Brief Title
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Official Title
A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (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 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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7791
Arm Type
Experimental
Arm Description
During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test.
KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible.
Intervention Type
Drug
Intervention Name(s)
KHK7791
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.
Description
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.
Time Frame
Dose period Week 1~52
Secondary Outcome Measure Information:
Title
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.
Description
To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis.
Important secondary endpoint
Time Frame
Week 1~52
Title
Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time Frame
Week 1~52
Title
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.
Time Frame
Week 1~52
Title
The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time Frame
Week 1~52
Title
The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time Frame
Week 1~52
Title
Concentration of serum phosphorous levels values at each time point.
Time Frame
Week 1~52
Title
Change of serum phosphorous levels from baseline values at each time point.
Time Frame
Week 1~52
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time Frame
Week 1~52
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time Frame
Week 1~52
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time Frame
Week 1~52
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time Frame
Week 1~52
Title
Concentrations of such as Ca × P product levels at each time point.
Time Frame
Week 1~52
Title
Changes of such as Ca × P product levels from baseline values at each time point.
Time Frame
Week 1~52
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 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.
Uncontrollable hypertension or diabetes
Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
Any diagnosis of or treatment of malignancy within 5 years before screening examination.
Facility Information:
Facility Name
Medical Corporation Seijinkai Ikeda Hospital
City
Kanoya
State/Province
Kagoshima
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Learn more about this trial
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
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