Phase 3 Study of KHK7580

Kyowa Kirin Co., Ltd.39 enrolled

Overview

This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

KHK7580DRUG

Oral administration

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Personally submitted written voluntary informed consent to participate in the study * Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening * Intact PTH level of \> 240 pg/ml at screening Exclusion Criteria: * Treatment with cinacalcet hydrochloride within 2 weeks before screening; * Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; * Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; * Severe heart disease; * Severe hepatic dysfunction; * Uncontrolled hypertension and/or diabetes; * Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; * Primary hyperparathyroidism; * Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL

Time frame: Weeks 30-32

Secondary Outcomes

Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline

Time frame: Weeks 30-32

Mean percent change in the evaluation period in intact PTH level from baseline

Time frame: Weeks 30-32

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.