NCT02143271

Brief Summary

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

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

May 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

May 14, 2014

Last Update Submit

March 3, 2015

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Number and types of adverse events

    The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram

    For 8 days

Secondary Outcomes (1)

  • Profiles of pharmacokinetics

    Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose

Study Arms (1)

KHK7580

EXPERIMENTAL
Drug: KHK7580

Interventions

KHK7580DRUG

Oral administration

KHK7580

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
  • intact parathyroid hormone value ≥ 240 pg/mL at the screening
  • Corrected serum calcium ≥ 8.4 mg/dL at the screening

You may not qualify if:

  • Patients with primary hyperparathyroidism
  • Patients who received cinacalcet within 2 weeks prior to the screening
  • Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
  • Patients who underwent parathyroidectomy and/or parathyroid intervention
  • Patients with uncontrolled hypertension and/or diabetes
  • Patients with severe heart disorder
  • Patients with severe hepatic disease
  • Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
  • Patients who have been judged ineligible to participate in the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyowa Hakko Kirin

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

JP(1)