Systemic Lupus ErythematosusCASTLENCT01520155
CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)
An observational study of Systemic Lupus Erythematosus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Dec 2012
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with or without systemic Lupus erythematosus
Who may be able to join
- Patients with systemic Lupus erythematosus
Who cannot join
- Patients without systemic Lupus erythematosus
Trial locations and contacts
1 site in 1 country.
Germany1 site
Frankfurt University Academic Medical Center
Frankfurt am Main, Hesse, 60590
About this study
Official title: CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE): Studie Zur Detektion Des kardiovaskulären Risikos in Patienten Mit Systemischem Lupus Erythematodes
The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.
Read the detailed description
Key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three group of patients will be compared as followed. First group are patients with known systemic Lupus erythematodes without renal affection, second group are patients with known systemic Lupus erythematodes with renal affection and the third group are patients with a non-autoimmun chronic kidney disease
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus erythematosus, cardiovascular risk
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus with renal affection | 30 patients will be investigated suffering from a known systemic lupus erythematosus with renal affection | |
| Systemic lupus erythematosus without renal affection | 30 patients will be investigated suffering from a known systemic lupus erythematosus without renal affection | |
| Non-autoimmune kidney disease | Patients with non-systemic, non-autoimmune kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Fox, Johann Wolfgang Goethe University Hospital
- Investigators
- Joachim R Ehrlich, MD, Study chair, Frankfurt University Academic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520155
- Sponsor's protocol ID
- sleffm001
- Acronym
- CASTLE
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2011
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE): Studie Zur Detektion Des kardiovaskulären Risikos in Patienten Mit Systemischem Lupus Erythematodes
- ClinicalTrials.gov ID
- NCT01520155
- Acronym / sponsor ID
- CASTLE / sleffm001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus erythematosus, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jan 2012 (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 key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.
Detailed description
Key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three group of patients will be compared as followed. First group are patients with known systemic Lupus erythematodes without renal affection, second group are patients with known systemic Lupus erythematodes with renal affection and the third group are patients with a non-autoimmun chronic kidney disease
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus with renal affection | – | –30 patients will be investigated suffering from a known systemic lupus erythematosus with renal affection |
| Systemic lupus erythematosus without renal affection | – | –30 patients will be investigated suffering from a known systemic lupus erythematosus without renal affection |
| Non-autoimmune kidney disease | – | –Patients with non-systemic, non-autoimmune kidney disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without systemic Lupus erythematosus
Key inclusion criteria (1 listed)
- Patients with systemic Lupus erythematosus
Key exclusion criteria (1 listed)
- Patients without systemic Lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes
Time frame: one year
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes
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 23 Dec 2013.
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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.
Joachim R Ehrlich, MD study chair
Frankfurt University Academic Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 23 Dec 2013. 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 Germany. 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.
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?
Identification of cardiovascular risk in patients with systemic Lupus Erythematodes (time frame: one year). 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 23 Dec 2013.