Phase 2 Study of KHK7580
A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
1 other identifier
interventional
201
1 country
1
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 KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 10, 2018
July 1, 2018
7 months
August 11, 2014
July 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The percent changes in intact Parathyroid hormone levels from baseline
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
Up to 3 weeks
Secondary Outcomes (2)
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Up to 3 weeks
Safety
Up to 3 weeks
Study Arms (5)
Plascebo
PLACEBO COMPARATORKHK7580 low dose
EXPERIMENTALKHK7580 middle dose
EXPERIMENTALKHK7580 high dose
EXPERIMENTALKRN1493
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 15, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 10, 2018
Record last verified: 2018-07