Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02143271

Enrollment

Registered

2014-05-21

Start date

2014-05-31

Completion date

2014-12-31

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

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.

Interventions

DRUGKHK7580

Oral administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number and types of adverse events	For 8 days	The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram

Secondary

Measure	Time frame	Description
Profiles of pharmacokinetics	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose	intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026