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

NCT01935856 | Completed Phase 1

• 1 other identifier: 7580-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperparathyroidism

Keywords

patients; receiving; hemodialysis; Secondary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Profiles of pharmacodynamics

  For 4-15 days after every dosing

Study Arms (1)

KHK7580

EXPERIMENTAL

Drug: KHK7580

Interventions

KHK7580 DRUG

Oral administration

KHK7580

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyperparathyroidism; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: September 2, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

JP (1)