Phase 2 Study of KHK7580

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Placebo; Drug: KRN1493; Drug: KHK7580 middle dose; Drug: KHK7580 high dose; Drug: KHK7580 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02216656

7580-005

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 5 patient groups, including a placebo group

Plascebo

Placebo Comparator group

Treatment:

Drug: Placebo

KHK7580 low dose

Experimental group

Treatment:

Drug: KHK7580 low dose

KHK7580 middle dose

Experimental group

Treatment:

Drug: KHK7580 middle dose

KHK7580 high dose

Experimental group

Treatment:

Drug: KHK7580 high dose

KRN1493

Active Comparator group

Treatment:

Drug: KRN1493