♦Basic information
JapicCTI-No. JapicCTI-142537
♦Title of the study
Title of the study A single-dose phase 1 study of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis
Public title of the study Phase 1 study of KHK7580
Primary sponsor Kyowa Hakko Kirin Co., Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis
♦Details of the study
Disease or condition Secondary hyperparathyroidism in patients receiving peritoneal dialysis
Intervention
Intervention name KHK7580
Classification name(code) of the intervention 399 (agents affecting metabolism n.e.c.)
Dosage And administration of the intervention Oral administration
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis
Study phase Phase 1
Study design Multicenter, open-label, single-dose study
Target sample size 8
Inclusion Criteria - Written informed consent
- Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
- intact PTH value >= 240 pg/mL at the screening

AgeF     20years old or more    75years old or less
SexF     Both
Exclusion Criteria

Outcome
Primary Outcome Safety
Timepoints Number and types of adverse events, laboratory tests, vital signs and electrocardiogram
Secondary Outcome  
Timepoints  
Institutions
Duration of the study 2014-4  `  2014-12
Study status
recruitment status Study Completed
Region
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Kyowa Hakko Kirin Co., Ltd.
Division Research & Development Planning Department , Research & Development Division
Contact person or e-mail address etc. clinical.info@kyowa-kirin.co.jp
Organization@(Scientific)
Division@(Scientific)
Contact person or e-mail address etc.@(Scientific)
♦Other
Source funded
Name of research funds
Other
♦History
History
2015/3/4   revised
2014/5/27   revised
2014/5/19   revised
2014/5/14   application date