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Completed

NCT Number: NCT02549391

Phase 3 Study of KHK7580

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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

  • Personally submitted written voluntary informed consent to participate in the study
  • Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
  • Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

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.

Treatment and study plan

KHK7580

Drug

Oral administration

KRN1493

Drug

Oral administration

Other names: cinacalcet hydrochloride

Primary outcomes

  1. 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 28-30

Secondary outcomes

  1. 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 28-30

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

    Time frame: Weeks 28-30

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Mar 24, 2017

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.

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