Lupus NephritisLuFlaNCT02313974
Lupus Flares and Histological Renal Activity at the End of the Treatment (LuFla)
An observational study of Lupus Nephritis, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
Trial summary
At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined. Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years. The factors associated to Renal relapses are not completly known. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Renal Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 2014to Nov 2018
- How long will I take part?
- 2 Years
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Proliferative Lupus Nephritis confirmed by renal biopsy
Who may be able to join
- Patients between 18 and 70 years old with Proliferative Lupus Nephritis
- 3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence
Who cannot join
- Membranous Nephropaty
- Mesangial Nephropathy
- Less than 3 years treatment
- Less than 1 year of complete remission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lupus Flares and Histological Renal Activity at the End of the Treatment
At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined.
Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years.
The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.
- Conditions
- Lupus Nephritis
- Being tested
- Renal Biopsy
- Keywords
- Lupus Nephritis Treatment, Renal Biopsy in Lupus, Lupus Flare
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal BiopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Flares
Renal relapse after a complete treatment in complete remission patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2018 (estimated)
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 Lupus NephritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas José de San Martín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo A De Rosa, MD, Hospital de Clinicas José de San Martín
- Investigators
- Marcelo A De Rosa, Physician, Principal investigator, Hospital de Clinicas. UBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313974
- Sponsor's protocol ID
- HSM LuNe
- Acronym
- LuFla
- Status last verified
- Sep 2016
- First submitted
- 8 Dec 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Rosa M, Azzato F, Toblli JE, De Rosa G, Fuentes F, Nagaraja HN, Nash R, Rovin BH. A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy. Kidney Int. 2018 Oct;94(4):788-794. doi: 10.1016/j.kint.2018.05.021. Epub 2018 Jul 23.
PubMed 30045812
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus Flares and Histological Renal Activity at the End of the Treatment
- ClinicalTrials.gov ID
- NCT02313974
- Acronym / sponsor ID
- LuFla / HSM LuNe
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis Treatment, Renal Biopsy in Lupus, Lupus Flare
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital de Clinicas José de San MartínUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 10 Dec 2014 (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.
At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined.
Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years.
The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Proliferative Lupus Nephritis confirmed by renal biopsy
Key inclusion criteria (2 listed)
- Patients between 18 and 70 years old with Proliferative Lupus Nephritis
- 3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence
Key exclusion criteria (4 listed)
- Membranous Nephropaty
- Mesangial Nephropathy
- Less than 3 years treatment
- Less than 1 year of complete remission
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 |
|---|---|---|
| Renal Biopsy | Procedure or surgery | – |
Primary outcome
Renal Flares
Time frame: 2 years
Renal relapse after a complete treatment in complete remission patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 30045812De Rosa M, Azzato F, Toblli JE, De Rosa G, Fuentes F, Nagaraja HN, Nash R, Rovin BH. A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy. Kidney Int. 2018 Oct;94(4):788-794. doi: 10.1016/j.kint.2018.05.021. Epub 2018 Jul 23.
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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.
Marcelo A De Rosa, Physician principal investigator
Hospital de Clinicas. UBA
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 Lupus Nephritis, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Sep 2016. 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 Argentina. 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?
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?
Renal Flares (time frame: 2 years). 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 NCT02313974, 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 14 Sep 2016.