NCT02549391

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 9, 2015

Last Update Submit

March 23, 2017

Conditions

Secondary Hyperparathyroidism

Outcome Measures

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

    Weeks 28-30

Secondary Outcomes (2)

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

    Weeks 28-30

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

    Weeks 28-30

Study Arms (2)

KHK7580

EXPERIMENTAL
Drug: KHK7580

KRN1493

ACTIVE COMPARATOR
Drug: KRN1493

Interventions

KHK7580DRUG

Oral administration

KHK7580
KRN1493DRUG

Oral administration

Also known as: cinacalcet hydrochloride
KRN1493

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tokyo, Japan

Location

Related Publications (2)

  • Tokumoto M, Tokunaga S, Asada S, Endo Y, Kurita N, Fukagawa M, Akizawa T. Predictive factors requiring high-dose evocalcet in hemodialysis patients with secondary hyperparathyroidism. PLoS One. 2022 Dec 13;17(12):e0279078. doi: 10.1371/journal.pone.0279078. eCollection 2022.

    PMID: 36512619DERIVED

  • Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T. Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism. PLoS One. 2022 Feb 17;17(2):e0262829. doi: 10.1371/journal.pone.0262829. eCollection 2022.

    PMID: 35176038DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

JP(1)