Secondary HyperparathyroidismPhase 1NCT02143271
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
A Phase 1 study testing KHK7580 in people with Secondary 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 administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteJapan
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 1
- 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 peritoneal dialysis for at least 16 weeks prior to the screening
- intact parathyroid hormone 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 who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
- Patients who underwent 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 another 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.
About this study
Official title: A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- KHK7580
- Keywords
- Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
- 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 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 and types of adverse events
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram
Measured: For 8 days
Secondary outcomes (1)
Profiles of pharmacokinetics
intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02143271
- Sponsor's protocol ID
- 7580-004
- Status last verified
- Mar 2015
- First submitted
- 14 May 2014
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02143271
- Acronym / sponsor ID
- 7580-004
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 May 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 study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.
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 peritoneal dialysis for at least 16 weeks prior to the screening
- intact parathyroid hormone 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 who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
- Patients who underwent 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
Number and types of adverse events
Time frame: For 8 days
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram
1 secondary outcome
Profiles of pharmacokinetics
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose
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 Mar 2015.
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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 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 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 5 Mar 2015. 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 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.
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 and types of adverse events (time frame: For 8 days). 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 5 Mar 2015.