Back to resultsClinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
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, Peritoneal Dialysis
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 peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.
- Dialysis conditions, 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 2 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.
Exclusion Criteria:
- Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.
- 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 in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.
- 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.
- Subjects who have undergone parathyroid intervention within 24 weeks before screening examination., or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study.
- 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.
Sites / Locations
- Inoue Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7791
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.
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
NCT04766385
First Posted
February 16, 2021
Last Updated
January 7, 2022
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04766385
Brief Title
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
Official Title
A Phase 3, Open-label, Single-arm Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 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 peritoneal dialysis 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, Peritoneal Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7791
Arm Type
Experimental
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
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 2, 4, 6, 8, 10, 12, 14, 16.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
Title
Concentrations of such as Ca × P product levels at each time point.
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
Title
Changes of such as Ca × P product levels from baseline values at each time point.
Time Frame
Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.
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 peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.
Dialysis conditions, 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 2 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.
Exclusion Criteria:
Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.
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 in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.
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.
Subjects who have undergone parathyroid intervention within 24 weeks before screening examination., or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study.
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.
Facility Information:
Facility Name
Inoue Hospital
City
Suita
State/Province
Osaka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
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