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Secondary HyperparathyroidismPhase 3NCT03822507

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

A Phase 3 study testing KHK7580 and Cinacalcet Hydrochloride in people with Secondary Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 34 sites in 4 countries.

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

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Secondary Hyperparathyroidism
What is being tested?
KHK7580 and Cinacalcet Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
34 sitesin 4 countries
Study dates
9 Apr 2019to 23 Sep 2021
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 18 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
  • Aged ≧18 years at the time of consent
  • Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
  • Intact PTH level (centrally measured) of >300 pg/mL at screening
  • Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Who cannot join

  • Treatment with cinacalcet hydrochloride within 2 weeks before screening
  • Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
  • Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
  • Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
  • Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
  • Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
  • Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
  • Uncontrolled hypertension and/or diabetes

Trial locations and contacts

34 sites in 4 countries.

34 sites in 4 countries

China13 sites

  • Research site_29

    Changsha

  • Research site_34

    Dalian

  • Research site_25

    Foshan

  • Research site_22

    Guangzhou

  • Research site_23

    Guangzhou

  • Research site_30

    Guangzhou

  • Research site_28

    Hefei

  • Research site_32

    Nanjing

  • Research site_33

    Nanjing

  • Research site_24

    Shanghai

  • Research site_26

    Shanghai

  • Research site_27

    Shanghai

  • Research site_31

    Wuxi

Other trials in China

South Korea10 sites

  • Research site_21

    Anyang

  • Research site_13

    Daegu

  • Research site_15

    Daegu

  • Research site_12

    Goyang

  • Research site_18

    Incheon

  • Research site_14

    Seoul

  • Research site_17

    Seoul

  • Research site_19

    Seoul

  • Research site_20

    Seoul

  • Research site_16

    Ulsan

Other trials in South Korea

Taiwan10 sites

  • Research site_2

    Kaohsiung City

  • Research site_3

    Kaohsiung City

  • Research site_5

    Kaohsiung City

  • Research site_9

    Taichung

  • Research site_4

    Tainan

  • Research site_7

    Tainan

  • Research site_10

    Taipei

  • Research site_1

    Taipei

  • Research site_6

    Taipei

  • Research site_8

    Taipei

Other trials in Taiwan

Hong Kong1 site

  • Research site_11

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

Being tested
KHK7580, Cinacalcet Hydrochloride
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

  • Cinacalcet HydrochlorideDrug

    oral administration

Study groups in NCT03822507
Study groupRoleWhat they receive
KHK7580 1mg-12mgExperimentalNot described
Receives: Drug: KHK7580
Cinacalcet 25mg-100mgActive comparatorNot described
Receives: Drug: Cinacalcet Hydrochloride

What is being measured

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

  1. Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period

    Measured: Week 50- Week 52

Secondary outcomes (7)

  1. Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period

    Measured: Week 50- Week 52

  2. Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period

    Measured: Week 50- Week 52

  3. Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period

    Measured: Week 50- Week 52

  4. Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period

    Measured: Week 50- Week 52

  5. Intact PTH level

    Measured: Week 50- Week 52

  6. corrected serum Ca level

    Measured: Week 50- Week 52

  7. serum P level

    Measured: Week 50- Week 52

Timeline

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

  1. First posted30 Jan 2019
  2. Study start9 Apr 2019
  3. Primary completion23 Sep 2021
  4. Study completion23 Sep 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822507
Sponsor's protocol ID
7580-201
Status last verified
Apr 2022
First submitted
29 Jan 2019
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KHK7580 and Cinacalcet Hydrochloride in people with Secondary Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 34 sites in 4 countries.

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 5 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, South Korea, Taiwan, Hong Kong. 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?

Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period (time frame: Week 50- Week 52). 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 NCT03822507.

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 25 Apr 2022.

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