Secondary HyperparathyroidismPhase 2NCT03226171
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
A Phase 2 study testing Dose-adjusted SK-1403 in people with Secondary Hyperparathyroidism, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial summary
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Dose-adjusted SK-1403
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jun 2017to 11 Sep 2018
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Average serum PTH>240 pg/mL during 2 weeks at the screening
- Serum corrected Ca≧8.4 mg/dL at the screening
- Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Who cannot join
- Primary hyperparathyroidism
- Severe liver disease
- Severe Cardiac disease
- History or family history of Long QT syndrome
- Malignant tumor
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- A history of severe drug allergy
Trial locations and contacts
1 site in 1 country.
Japan1 site
Investigational site (there may be other sites in this country)
Tokyo
About this study
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Dose-adjusted SK-1403
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-adjusted SK-1403Drug
SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
| Study group | Role | What they receive |
|---|---|---|
| Dose-adjusted SK-1403 | Experimental | Not described Receives: Drug: Dose-adjusted SK-1403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Assessed by laboratory test value
Measured: 18 weeks
Secondary outcomes (2)
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Assessed by laboratory test value
Measured: 18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Assessed by laboratory test value
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Jun 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226171
- Sponsor's protocol ID
- AJ1002
- Status last verified
- Mar 2019
- First submitted
- 20 Jul 2017
- Last updated
- 15 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03226171
- Acronym / sponsor ID
- AJ1002
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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 conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-adjusted SK-1403 | Experimental | Drug: Dose-adjusted SK-1403 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Average serum PTH>240 pg/mL during 2 weeks at the screening
- Serum corrected Ca≧8.4 mg/dL at the screening
- Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Key exclusion criteria (8 listed)
- Primary hyperparathyroidism
- Severe liver disease
- Severe Cardiac disease
- History or family history of Long QT syndrome
- Malignant tumor
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 |
|---|---|---|
| Dose-adjusted SK-1403SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment | Drug | Dose-adjusted SK-1403 |
Primary outcome
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Time frame: 18 weeks
Assessed by laboratory test value
2 secondary outcomes
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Time frame: 18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Time frame: 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 15 Mar 2019.
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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 Dose-adjusted SK-1403 in people with Secondary Hyperparathyroidism, run by Sanwa Kagaku Kenkyusho 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 15 Mar 2019. 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 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?
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive (time frame: 18 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 15 Mar 2019.