Phase 3 Study of KHK7580

NCT02549404 | Completed Phase 3

• 1 other identifier: 7580-011
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Adverse Event collection and assessment

  Up to 52 weeks

Secondary Outcomes (3)

• Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL

  Up to 52 weeks

• Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline

  Up to 52 weeks

• Mean percent change in intact PTH level from baseline

  Up to 52 weeks

Study Arms (1)

KHK7580

EXPERIMENTAL

Drug: KHK7580

Interventions

KHK7580 DRUG

Oral administration

KHK7580

Eligibility Criteria

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

You may qualify if:

• Personally submitted written voluntary informed consent to participate in the study
• Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
• Intact PTH level of \> 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)

You may not qualify if:

• Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
• Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
• Severe heart disease;
• Severe hepatic dysfunction;
• Uncontrolled hypertension and/or diabetes;
• Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
• Primary hyperparathyroidism;
• Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

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, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 15, 2015
• Study Start: September 28, 2015
• Primary Completion: December 6, 2016
• Study Completion: December 28, 2016
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

JP (1)