Phase 2 Study of KHK7580

Secondary Hyperparathyroidism Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216656
• Other study ID #: 7580-005
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2018
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• Placebo
Oral administration
• KHK7580 low dose
Oral administration
• KHK7580 middle dose
Oral administration
• KHK7580 high dose
Oral administration
• KRN1493
Oral administration

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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 from baseline to end of administrations period.	Up to 3 weeks
Secondary	Safety	Number and types of adverse events; laboratory tests; vital signs; 12-lead electrocardiogram; ophthalmological examination	Up to 3 weeks