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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
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Tenapanor, Hyperphosphatemia, Hemodialysis

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 4, 2019
Last Updated
January 14, 2020
Sponsor
Kyowa Kirin Co., Ltd.
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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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