Kidney Failure, ChronicPhase 4NCT00091481
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
A Phase 4 study testing Zemplar in people with Kidney Failure, Chronic, run by Abbott at 19 sites in Greece.
Trial summary
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Zemplar
- How many people
- 201 participants
- Where
- 19 sitesGreece
- Study dates
- Jun 2003to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage V Chronic Kidney Disease
- Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Greece19 sites
Errikos Dynan Hospital
Ambelokipi, Athens, 11526
Blue Cross Clinic
Athens, 11528
Evgenidio Clinic
Athens, 11528
Regional General Hospital of Athens "Korgialeneio-Benakeio"
Athens
General Hospital of Athens, "G.Gennimatas"
Cholargós, Athens, 11527
General University Hospital of Alexandroupolis
Dragana, 68100
General Hospital Thessaloniki "Papanikolaou"
Eksochi, Thessaloniki, 570 10
Regional General Hospital of Ioannina "Hatzikosta"
Ioannina, 450 01
General University Hospital Ioannina
Ioannina, 455 00
General Hospital of Attica "Sismanoglio"
Marousi, Athens, 15126
"Hygeia" Diagnosis and Therapy Center
Marousi, Athens, 152 00
General Hospital of Melissia "Amalia Fleming"
Melíssia, Athens, 15127
General Hospital of Nikea "Agios Panteleimon"
Nikea, Piraeus 18454,
General Hospital of Veria
Papagou Area, Veria
General Hospital of Thessaloniki "Ahepa"
Thessaloniki
General Hospital of Thessaloniki "Hippokrateion"
Thessaloniki
General Hospital of Thessaloniki "Papageorgiou"
Thessaloniki
General Hospital of Voula Askilpieion
Voula, Athens, 16673
General Hospital of Heraklion
Voutes, Heraklion, Crete
About this study
Official title: A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).
- Conditions
- Kidney Failure, Chronic
- Being tested
- Zemplar
- Keywords
- Stage V Chronic Kidney Disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZemplarDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
Secondary outcomes (3)
Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
The incidence rate for hypercalcemia
The incidence rate for hyperphosphatemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jin Tian, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091481
- Sponsor's protocol ID
- M01-367
- Status last verified
- Sep 2007
- First submitted
- 9 Sep 2004
- Last updated
- 26 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
- ClinicalTrials.gov ID
- NCT00091481
- Acronym / sponsor ID
- M01-367
- Conditions
- Kidney Failure, Chronic
- Keywords
- Stage V Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- First posted
- 13 Sep 2004 (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.
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage V Chronic Kidney Disease
- Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Zemplar | Drug | – |
Primary outcome
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
3 secondary outcomes
Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
The incidence rate for hypercalcemia
The incidence rate for hyperphosphatemia
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 26 Sep 2007.
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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.
Jin Tian, M.D. study director
Abbott
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zemplar in people with Kidney Failure, Chronic, run by Abbott at 19 sites 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 2 inclusion and 0 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 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 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?
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.. 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 26 Sep 2007.