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Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7791
Placebo
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has voluntarily provided written informed consent to participate in the study.
  2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
  3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
  4. Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
  5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
  6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
  7. 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.
  8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion Criteria:

  1. Peritoneal dialysis was performed within 12 weeks before screening examination.
  2. iPTH >600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
  3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
  4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
  5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
  6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
  7. Having concurrent severe heart disease or hepatic impairment.
  8. Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.
  9. Uncontrollable hypertension or diabetes.
  10. 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.
  11. 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

  • Inoue Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KHK7791

Placebo

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.

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

First Posted
February 16, 2021
Last Updated
October 26, 2021
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04766398
Brief Title
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 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 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK7791
Arm Type
Active Comparator
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
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
Intervention Type
Drug
Intervention Name(s)
Placebo
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 1, 2, 3, 4, 5, 6, 7, 8.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Concentrations of such as Ca × P product levels at each time point.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Title
Changes of such as Ca × P product levels from baseline values at each time point.
Time Frame
Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.

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 ≤ 6.0 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 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 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. Having concurrent severe heart disease or hepatic impairment. Developed cerebrovascular disease 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
Inoue Hospital
City
Suita
State/Province
Osaka
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

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