Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Hyperparathyroidism Clinical Trial

Official title:

A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935856
• Other study ID #: 7580-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 2, 2013
• Last updated: February 28, 2017
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Written informed consent

• Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening

• intact PTH 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 with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening

• Patients who received 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 other clinical trial within 12 weeks prior to the screening

• Patients who have been judged ineligible to participate in the study by the investigator

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary

Intervention

Drug:
• KHK7580
Oral administration

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination	The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination	For 19 weeks
Secondary	Profiles of pharmacokinetics	Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period
Secondary	Profiles of pharmacodynamics	intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin	For 4-15 days after every dosing