Back to resultsA Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 2
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:
- Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination.
- Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment.
- Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.
- If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination.
Exclusion Criteria:
- 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.
- Severe heart disease (including congestive heart failure, defined as New York Heart Association [NYHA] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent cirrhosis.
- Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) 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 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 (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Sites / Locations
- Study Site 1
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7791
Arm Description
Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question.
Outcomes
Primary Outcome Measures
Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.
Secondary Outcome Measures
Serum phosphorus levels at each time point after the start of treatment
Corrected serum calcium level at each time point after the start of treatment
Full Information
NCT ID
NCT03831607
First Posted
January 29, 2019
Last Updated
January 14, 2020
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03831607
Brief Title
A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
Official Title
A Phase 2, Open-label Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (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 effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7791
Arm Type
Experimental
Arm Description
Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question.
Intervention Type
Drug
Intervention Name(s)
KHK7791
Other Intervention Name(s)
Tenapanor
Intervention Description
KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets
Primary Outcome Measure Information:
Title
Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Serum phosphorus levels at each time point after the start of treatment
Time Frame
up to Week 26
Title
Corrected serum calcium level at each time point after the start of treatment
Time Frame
up to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination.
Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment.
Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.
If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination.
Exclusion Criteria:
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.
Severe heart disease (including congestive heart failure, defined as New York Heart Association [NYHA] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent cirrhosis.
Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) 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 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 (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Facility Information:
Facility Name
Study Site 1
City
Niigata
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
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