Chronic Kidney DiseasePhase 2NCT00646932
Paricalcitol Injection Phase II Trial
A Phase 2 study testing paricalcitol in people with Chronic Kidney Disease, run by Abbott at 10 sites in Japan.
Trial summary
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- paricalcitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesJapan
- Study dates
- Nov 2005to Feb 2007
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure
Who cannot join
- Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Gunma
Study site
Hokkaido
Study site
Ibaraki
Study site
Kagoshima
Study site
Kumamoto
Study site
Nagano
Study site
Nagasaki
Study site
Saitama
Study site
Shizuoka
Study site
Tokyo
About this study
Official title: A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism Undergoing Hemodialysis
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.
Read the detailed description
The purpose of this study is pharmacokinetic \& tolerability.
- Conditions
- Chronic Kidney Disease
- Being tested
- paricalcitol
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Also called ABT-358, Zemplar
paricalcitol 0.04 mcg/kg three times a week
paricalcitolDrug
Also called ABT-358, Zemplar
paricalcitol 0.08 mcg/kg three times a week
paricalcitolDrug
Also called ABT-358, Zemplar
paricalcitol 0.16 mcg/kg three times a week
paricalcitolDrug
Also called ABT-358, Zemplar
paricalcitol 0.24 mcg/kg three times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: paricalcitol |
| 2 | Experimental | Not described Receives: Drug: paricalcitol |
| 3 | Experimental | Not described Receives: Drug: paricalcitol |
| 4 | Experimental | Not described Receives: Drug: paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: 2 weeks
Secondary outcomes (1)
Safety
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startNov 2005
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hideaki Harada, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646932
- Sponsor's protocol ID
- J-ZEM-05-002
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT00646932
- Acronym / sponsor ID
- J-ZEM-05-002
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2007 (actual)
- First posted
- 31 Mar 2008 (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 PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.
Detailed description
The purpose of this study is pharmacokinetic \& tolerability.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: paricalcitol |
| 2 | Experimental | Drug: paricalcitol |
| 3 | Experimental | Drug: paricalcitol |
| 4 | Experimental | Drug: paricalcitol |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure
Key exclusion criteria (1 listed)
- Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study
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 |
|---|---|---|
| paricalcitolAlso: ABT-358, Zemplarparicalcitol 0.04 mcg/kg three times a week | Drug | 1 |
| paricalcitolAlso: ABT-358, Zemplarparicalcitol 0.08 mcg/kg three times a week | Drug | 2 |
| paricalcitolAlso: ABT-358, Zemplarparicalcitol 0.16 mcg/kg three times a week | Drug | 3 |
| paricalcitolAlso: ABT-358, Zemplarparicalcitol 0.24 mcg/kg three times a week | Drug | 4 |
Primary outcome
Pharmacokinetics
Time frame: 2 weeks
1 secondary outcome
Safety
Time frame: 2 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 31 Mar 2008.
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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.
Hideaki Harada study director
Abbott
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paricalcitol in people with Chronic Kidney Disease, run by Abbott at 10 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 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Pharmacokinetics (time frame: 2 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 31 Mar 2008.