Primary Hypophosphatemic RicketsPhase 3NCT01237288
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
A Phase 3 study testing Z-521 in people with Primary Hypophosphatemic Rickets, run by Zeria Pharmaceutical at 4 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Primary Hypophosphatemic Rickets
- What is being tested?
- Z-521
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesJapan
- Study dates
- Sep 2010to Jul 2013
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.
Who cannot join
- A hyperparathyroidism
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Chiba Children's Hospital
Chiba
Kanagawa Children's Medical Center
Kanagawa
Osaka University Hospital
Osaka
Tokyo Metropolitan Children's Medical Center
Tokyo
About this study
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.
- Conditions
- Primary Hypophosphatemic Rickets
- Being tested
- Z-521
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-521Drug
| Study group | Role | What they receive |
|---|---|---|
| Z-521 | Experimental | Not described Receives: Drug: Z-521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ALP level
Measured: 6 month
Serum phosphate level
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Hypophosphatemic RicketsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keiichi Ozono, M.D., Ph.D., Study chair, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237288
- Sponsor's protocol ID
- 10010301
- Status last verified
- Sep 2013
- First submitted
- 7 Nov 2010
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ozono K, Hasegawa Y, Minagawa M, Adachi M, Namba N, Kazukawa I, Kitaoka T, Asakura Y, Shimura A, Naito Y. Therapeutic use of oral sodium phosphate (phosribbon((R)) combination granules) in hereditary hypophosphatemic rickets. Clin Pediatr Endocrinol. 2014 Jan;23(1):9-15. doi: 10.1292/cpe.23.9. Epub 2014 Feb 3.
PubMed 24532956
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
- ClinicalTrials.gov ID
- NCT01237288
- Acronym / sponsor ID
- 10010301
- Conditions
- Primary Hypophosphatemic Rickets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Nov 2010 (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.
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Z-521 | Experimental | Drug: Z-521 |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.
Key exclusion criteria (1 listed)
- A hyperparathyroidism
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 |
|---|---|---|
| Z-521 | Drug | Z-521 |
Primary outcome
Serum ALP level
Time frame: 6 month
Serum phosphate level
Time frame: 6 month
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 1 Oct 2013.
- Derived from this study: PubMed 24532956Ozono K, Hasegawa Y, Minagawa M, Adachi M, Namba N, Kazukawa I, Kitaoka T, Asakura Y, Shimura A, Naito Y. Therapeutic use of oral sodium phosphate (phosribbon((R)) combination granules) in hereditary hypophosphatemic rickets. Clin Pediatr Endocrinol. 2014 Jan;23(1):9-15. doi: 10.1292/cpe.23.9. Epub 2014 Feb 3.
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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.
Keiichi Ozono, M.D., Ph.D. study chair
Osaka University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Z-521 in people with Primary Hypophosphatemic Rickets, run by Zeria Pharmaceutical at 4 sites 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 1 inclusion and 1 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Serum ALP level (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT01237288, which also lists 1 linked publication.
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 1 Oct 2013.