Secondary HyperparathyroidismPhase 4NCT00446329
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
A Phase 4 study testing cinacalcet in people with Secondary Hyperparathyroidism, run by Papageorgiou General Hospital at 1 site in Greece.
Trial summary
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- cinacalcet
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2006to not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 yrs
- On hemodialysis for at least 3 months (thrice weekly)
- iPTH >300pg/ml or histological evidence of secondary hyperparathyroidism
- Calcium > 8.1 mg/dl
Who cannot join
- Unstable clinical condition
Trial locations and contacts
1 site in 1 country.
About this study
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.
The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- cinacalcet
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcetDrug
Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Measured: one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJul 2006
Why it stopped: due to financial problems
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papageorgiou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efstathios Mitsopoulos, Papageorgiou General Hospital
- Investigators
- Efstathios Mitsopoulos, MD, Principal investigator, Papageorgiou General Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446329
- Sponsor's protocol ID
- 109/16-01-2007
- Status last verified
- Oct 2014
- First submitted
- 9 Mar 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT00446329
- Acronym / sponsor ID
- 109/16-01-2007
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to financial problems
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Papageorgiou General HospitalUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 12 Mar 2007 (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 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.
The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 18 yrs
- On hemodialysis for at least 3 months (thrice weekly)
- iPTH >300pg/ml or histological evidence of secondary hyperparathyroidism
- Calcium > 8.1 mg/dl
Key exclusion criteria (1 listed)
- Unstable clinical condition
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 |
|---|---|---|
| cinacalcetInitiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day. | Drug | – |
Primary outcome
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Time frame: one year period
Results and safety
The study was stopped early (reason given: due to financial problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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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.
Efstathios Mitsopoulos, MD principal investigator
Papageorgiou General Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cinacalcet in people with Secondary Hyperparathyroidism, run by Papageorgiou General Hospital at 1 site in Greece.
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 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: stopped early, as of the sponsor's last update on 29 Oct 2014. 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 Greece. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: due to financial problems). Results are not available in the source record.
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?
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients (time frame: one year period). 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 29 Oct 2014.