HyperparathyroidismPhase 1/2NCT01935856
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
A Phase 1/2 study testing KHK7580 in people with Hyperparathyroidism, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- 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
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2013to Mar 2014
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
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 Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
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
- Being tested
- KHK7580
- Keywords
- patients, receiving, hemodialysis, Secondary
- Medical subject headings
- Hyperparathyroidism, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK7580Drug
Oral administration
| 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.
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
Measured: For 19 weeks
Secondary outcomes (2)
Profiles of pharmacokinetics
Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.
Measured: 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
intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin
Measured: For 4-15 days after every dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01935856
- Sponsor's protocol ID
- 7580-003
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT01935856
- Acronym / sponsor ID
- 7580-003
- Conditions
- Hyperparathyroidism
- Keywords
- patients, receiving, hemodialysis, Secondary
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Sep 2013 (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 study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients 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 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
Time frame: For 19 weeks
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
2 secondary outcomes
Profiles of pharmacokinetics
Time frame: 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
Time frame: For 4-15 days after every dosing
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 3 Mar 2017.
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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 1/2 study testing KHK7580 in people with 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 4 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 3 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination (time frame: For 19 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 3 Mar 2017.