Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Primary Purpose
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 Hyperparathyroidism focused on measuring patients, receiving, hemodialysis, Secondary
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening
- intact PTH 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 with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
- Patients who received 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 other 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
- For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7580
Arm Description
Outcomes
Primary Outcome Measures
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
Secondary Outcome Measures
Profiles of pharmacokinetics
Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.
Profiles of pharmacodynamics
intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin
Full Information
NCT ID
NCT01935856
First Posted
September 2, 2013
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01935856
Brief Title
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Official Title
A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 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 and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
patients, receiving, hemodialysis, Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (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
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
Description
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
Time Frame
For 19 weeks
Secondary Outcome Measure Information:
Title
Profiles of pharmacokinetics
Description
Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.
Time Frame
Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period
Title
Profiles of pharmacodynamics
Description
intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin
Time Frame
For 4-15 days after every dosing
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 hemodialysis 3 times weekly for at least 12 weeks prior to the screening
intact PTH 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 with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
Patients who received 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 other 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
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
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