Secondary HyperparathyroidismPhase 3NCT02549404

Phase 3 Study of KHK7580

A Phase 3 study testing KHK7580 in people with Secondary Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Secondary Hyperparathyroidism
What is being tested?: KHK7580
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteJapan
Study dates: 28 Sep 2015to 28 Dec 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

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

Other trials in Japan

About this study

Official title: Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

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
Being tested: KHK7580
Medical subject headings: Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KHK7580Drug
Oral administration

Study groups in NCT02549404
Study group	Role	What they receive
KHK7580	Experimental	Not described Receives: Drug: KHK7580

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
Adverse Event collection and assessment
Measured: Up to 52 weeks

Secondary outcomes (3)

Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Measured: Up to 52 weeks
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Measured: Up to 52 weeks
Mean percent change in intact PTH level from baseline
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 201528 Dec 2016

First posted15 Sep 2015 (estimated)
Study start28 Sep 2015
Primary completion6 Dec 2016
Study completion28 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02549404
Sponsor's protocol ID: 7580-011
Status last verified: Jul 2017
First submitted: 9 Sep 2015
Last updated: 5 Jul 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Hyperparathyroidism, Secondary, Kidney Failure, Chronic

All Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)
ClinicalTrials.gov ID: NCT02549404
Acronym / sponsor ID: 7580-011
Conditions: Secondary Hyperparathyroidism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Sep 2015
Primary completion: 6 Dec 2016 (actual)
Study completion: 28 Dec 2016 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
KHK7580	Experimental	Drug: KHK7580

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KHK7580Oral administration	Drug	KHK7580

Primary outcome

Number of participants with adverse events
Time frame: Up to 52 weeks
Adverse Event collection and assessment

3 secondary outcomes

Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Time frame: Up to 52 weeks
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Time frame: Up to 52 weeks
Mean percent change in intact PTH level from baseline
Time frame: Up to 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.

Related trials for Secondary Hyperparathyroidism

Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Hyperparathyroidism, Secondary, Kidney Failure, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KHK7580 in people with Secondary Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02549404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.