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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01935856

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism	Drug: KHK7580	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KHK7580	Drug: KHK7580 Oral administration

Arm

Intervention/Treatment

Experimental: KHK7580

Drug: KHK7580

Oral administration

Outcome Measures

Primary Outcome Measures

The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination [For 19 weeks]
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination

Secondary Outcome Measures

Profiles of pharmacokinetics [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]
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.
Profiles of pharmacodynamics [For 4-15 days after every dosing]
intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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