Phase 2 Study of KHK7580

July 8, 2018 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Plascebo
Drug: Placebo
Oral administration
EXPERIMENTAL: KHK7580 low dose
Drug: KHK7580 low dose
Oral administration
EXPERIMENTAL: KHK7580 middle dose
Drug: KHK7580 middle dose
Oral administration
EXPERIMENTAL: KHK7580 high dose
Drug: KHK7580 high dose
Oral administration
ACTIVE_COMPARATOR: KRN1493
Drug: KRN1493
Oral administration
Other Names:
  • cinacalcet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 weeks
Safety
Time Frame: Up to 3 weeks
  1. Number and types of adverse events
  2. laboratory tests
  3. vital signs
  4. 12-lead electrocardiogram
  5. ophthalmological examination
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (ESTIMATE)

August 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 8, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7580-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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