Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143271
• Other study ID #: 7580-004
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2014
• Last updated: March 3, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• KHK7580
Oral administration

Locations

Country	Name	City	State
Japan	Kyowa Hakko Kirin	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Profiles of pharmacokinetics	intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose	No