Status:
COMPLETED
Phase 2 Study of KHK7580
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7...
Eligibility Criteria
Inclusion
- Subjects who have voluntarily consented to participate in this study
- Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
- Subjects with an intact Parathyroid hormone of \>= 240 pg/mL at screening
Exclusion
- Subjects with primary hyperparathyroidism
- Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
- Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
- Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
- Subjects with uncontrolled hypertension and/or diabetes
- Subjects with severe heart disease.
- Subjects with severe hepatic dysfunction.
- Subjects who have received any other investigational drug within 12 weeks before screening
- Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT02216656
Start Date
July 1 2014
End Date
February 1 2015
Last Update
July 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, Japan