Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KHK7580
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
- intact parathyroid hormone value ≥ 240 pg/mL at the screening
- Corrected serum calcium ≥ 8.4 mg/dL at the screening
Exclusion Criteria:
- Patients with primary hyperparathyroidism
- Patients who received cinacalcet within 2 weeks prior to the screening
- Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
- Patients who underwent parathyroidectomy and/or parathyroid intervention
- Patients with uncontrolled hypertension and/or diabetes
- Patients with severe heart disorder
- Patients with severe hepatic disease
- Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
- Patients who have been judged ineligible to participate in the study by the investigator
Sites / Locations
- Kyowa Hakko Kirin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7580
Arm Description
Outcomes
Primary Outcome Measures
Number and types of adverse events
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram
Secondary Outcome Measures
Profiles of pharmacokinetics
intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02143271
Brief Title
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Official Title
A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7580
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK7580
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Number and types of adverse events
Description
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram
Time Frame
For 8 days
Secondary Outcome Measure Information:
Title
Profiles of pharmacokinetics
Description
intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin
Time Frame
Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
intact parathyroid hormone value ≥ 240 pg/mL at the screening
Corrected serum calcium ≥ 8.4 mg/dL at the screening
Exclusion Criteria:
Patients with primary hyperparathyroidism
Patients who received cinacalcet within 2 weeks prior to the screening
Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
Patients who underwent parathyroidectomy and/or parathyroid intervention
Patients with uncontrolled hypertension and/or diabetes
Patients with severe heart disorder
Patients with severe hepatic disease
Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
Patients who have been judged ineligible to participate in the study by the investigator
Facility Information:
Facility Name
Kyowa Hakko Kirin
City
Tokyo
Country
Japan
12. IPD Sharing Statement
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Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
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