Secondary HyperparathyroidismPhase 2NCT02216656
Phase 2 Study of KHK7580
A Phase 2 study testing KHK7580 low dose, KHK7580 middle dose and KHK7580 high dose in people with Secondary Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- KHK7580 low dose, KHK7580 middle dose and KHK7580 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Feb 2015
- Phase
- Phase 2
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have voluntarily consented to participate in this study
- Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
- Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening
Who cannot join
- Subjects with primary hyperparathyroidism
- Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
- Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
- Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
- Subjects with uncontrolled hypertension and/or diabetes
- Subjects with severe heart disease.
Show all 9Show fewer
- Subjects with severe hepatic dysfunction.
- Subjects who have received any other investigational drug within 12 weeks before screening
- Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
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
About this study
Official title: A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Placebo, KHK7580 low dose, KHK7580 middle dose, KHK7580 high dose, KRN1493
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral administration
KHK7580 low doseDrug
Oral administration
KHK7580 middle doseDrug
Oral administration
KHK7580 high doseDrug
Oral administration
KRN1493Drug
Also called cinacalcet
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Plascebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KHK7580 low dose | Experimental | Not described Receives: Drug: KHK7580 low dose |
| KHK7580 middle dose | Experimental | Not described Receives: Drug: KHK7580 middle dose |
| KHK7580 high dose | Experimental | Not described Receives: Drug: KHK7580 high dose |
| KRN1493 | Active comparator | Not described Receives: Drug: KRN1493 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent changes in intact Parathyroid hormone levels from baseline
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
Measured: Up to 3 weeks
Secondary outcomes (2)
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.
Measured: Up to 3 weeks
Safety
- Number and types of adverse events
- laboratory tests
- vital signs
- 12-lead electrocardiogram
- ophthalmological examination
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216656
- Sponsor's protocol ID
- 7580-005
- Status last verified
- Jul 2018
- First submitted
- 11 Aug 2014
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT02216656
- Acronym / sponsor ID
- 7580-005
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Aug 2014 (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 randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Plascebo | Placebo comparator | Drug: Placebo |
| KHK7580 low dose | Experimental | Drug: KHK7580 low dose |
| KHK7580 middle dose | Experimental | Drug: KHK7580 middle dose |
| KHK7580 high dose | Experimental | Drug: KHK7580 high dose |
| KRN1493 | Active comparator | Drug: KRN1493 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have voluntarily consented to participate in this study
- Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
- Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening
Key exclusion criteria (9 listed)
- Subjects with primary hyperparathyroidism
- Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
- Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
- Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
- Subjects with 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 |
|---|---|---|
| PlaceboOral administration | Drug | Plascebo |
| KHK7580 low doseOral administration | Drug | KHK7580 low dose |
| KHK7580 middle doseOral administration | Drug | KHK7580 middle dose |
| KHK7580 high doseOral administration | Drug | KHK7580 high dose |
| KRN1493Also: cinacalcetOral administration | Drug | KRN1493 |
Primary outcome
The percent changes in intact Parathyroid hormone levels from baseline
Time frame: Up to 3 weeks
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
2 secondary outcomes
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Time frame: Up to 3 weeks
Safety
Time frame: Up to 3 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 10 Jul 2018.
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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 2 study testing KHK7580 low dose, KHK7580 middle dose and KHK7580 high dose 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 9 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 10 Jul 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The percent changes in intact Parathyroid hormone levels from baseline (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2018.