Skip to main content
OpenTrials
Completed

NCT Number: NCT02216656

Phase 2 Study of KHK7580

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Oral administration

KHK7580 low dose

Drug

Oral administration

KHK7580 middle dose

Drug

Oral administration

KHK7580 high dose

Drug

Oral administration

KRN1493

Drug

Oral administration

Other names: cinacalcet

Primary outcomes

  1. The percent changes in intact Parathyroid hormone levels from baseline

    Time frame: Up to 3 weeks

    Percent changes in intact Parathyroid hormone levels from baseline to end of administration period

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. Safety

    Time frame: Up to 3 weeks

    • Number and types of adverse events
    • laboratory tests
    • vital signs
    • 12-lead electrocardiogram
    • ophthalmological examination

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 15, 2014
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.