Phase 2 Study of KHK7580

Phase 2

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Placebo; Drug: KHK7580 middle dose; Drug: KRN1493; Drug: KHK7580 low dose; Drug: KHK7580 high dose

• Registration Number: NCT02216656
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-08
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plascebo	Placebo	-
KHK7580 middle dose	KHK7580 middle dose	-
KRN1493	KRN1493	-
KHK7580 low dose	KHK7580 low dose	-
KHK7580 high dose	KHK7580 high dose	-

Primary Outcome Measures

Name	Time	Method
The percent changes in intact Parathyroid hormone levels from baseline	Up to 3 weeks	Percent changes in intact Parathyroid hormone levels from baseline to end of administration period

Secondary Outcome Measures

Name	Time	Method
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	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.
Safety	Up to 3 weeks	1. Number and types of adverse events; 2. laboratory tests; 3. vital signs; 4. 12-lead electrocardiogram; 5. ophthalmological examination

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin; 🇯🇵 Tokyo, Japan