Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KHK7791
Placebp
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring Tenapanor, Hyperphosphatemia, Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- Patients with stable chronic renal failure who have undergone hemodialysis three 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.
- Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination.
- Serum phosphorus levels should be in the range of ≥6.1 and ≤10.0 mg/dL at screening examination.
- If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
Exclusion Criteria:
- 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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
- Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as 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 change in the dialysis center (relocate to another hospital/clinic) during the study period.
- Any diagnosis of and 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 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KHK7791
Placebo
Arm Description
Patients take KHK7791 BID and can down titrate, based on a GI tolerability question.
Patients take Placebo BID.
Outcomes
Primary Outcome Measures
Comparing changes in serum phosphorus levels between hemodialysis patients taking KHK7791 in combination with phosphate binders and those taking placebo in combination with phosphate binders.
Secondary Outcome Measures
Changes in serum Ca × P levels from baseline.
Changes in corrected serum calcium levels from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03864445
Brief Title
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination 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
April 29, 2019 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 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 KHK7791 in combination with phosphate binders to treat Hyperphosphatemia in ptatients 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7791
Arm Type
Experimental
Arm Description
Patients take KHK7791 BID and can down titrate, based on a GI tolerability question.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients take Placebo BID.
Intervention Type
Drug
Intervention Name(s)
KHK7791
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebp
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Comparing changes in serum phosphorus levels between hemodialysis patients taking KHK7791 in combination with phosphate binders and those taking placebo in combination with phosphate binders.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Changes in serum Ca × P levels from baseline.
Time Frame
Week 6
Title
Changes in corrected serum calcium levels from baseline.
Time Frame
Week 6
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:
Patients with stable chronic renal failure who have undergone hemodialysis three 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.
Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination.
Serum phosphorus levels should be in the range of ≥6.1 and ≤10.0 mg/dL at screening examination.
If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
Exclusion Criteria:
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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as 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 change in the dialysis center (relocate to another hospital/clinic) during the study period.
Any diagnosis of and 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
Chiba
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
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