Lupus NephritisPhase 3Csa-LESNCT01299922
Clinical Trial Treatment in Lupus Nephritis
A Phase 3 study testing cyclosporine +mycophenolic acid+prednison and Mycophenolic Acid + prednison in people with Lupus Nephritis, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
Trial summary
The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- cyclosporine +mycophenolic acid+prednison and Mycophenolic Acid + prednison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Oct 2014
- Phase
- Phase 3
- 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 > 18 years old
- Patients diagnosed SLE with renal type III-IV-V confirmed by renal biopsy done in the last 6 months
- Proteinuria > 2 g/24 hours and hematuria (> 5 h / field)
- MDRD4 eGFR > 60 ml/min/1.73m2
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- Central nervous system LES involvement or any other vital organ
- Active infection
- Use of mycophenolic acid, mycophenolate mofetil, cyclosporine or tacrolimus in the last 6 months
- No adherence
- Women of childbearing age not using appropriate contraceptive methods.
- Positive pregnancy test
Show all 9Show fewer
- Anasarca
- Malignancy or cancer history (except basal cell skin carcinomas)
- Patient participating in another study with an investigational drug or have participated within 28 days prior to entry into this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, Open, Randomized, Parallel-group Clinical Trial, to Evaluate the Efficacy and Safety of Treatment With Prednisone, Cyclosporine, Mycophenolic Acid Versus Prednisone and Mycophenolic Acid in Lupus Nephritis Type III-IV-V.
The treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side effects, especially for long term. The association of prednison and mycophenolate has created large expectations to that effect, and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.
Despite the significant advances that have led to these treatments, the likelihood of complete remission after six months remains, according to the series of 8-13% and partial remission do not exceed 60% in papers published. In the last year, two articles have been published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in poor prognosis of lupus nephritis with hopefully better results than those obtained previously. In this study we try to compare the effectiveness of triple therapy, the therapy is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type III-IV-V
Read the detailed description
asd
- Conditions
- Lupus Nephritis
- Being tested
- cyclosporine +mycophenolic acid+prednison, Mycophenolic Acid + prednison
- Keywords
- Lupus nephritis, Therapy, Cyclosporin, Mycophenolic acid
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine +mycophenolic acid+prednisonDrug
Also called Triple therapy
Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
Mycophenolic Acid + prednisonDrug
Also called Conventional therapy
Mycophenolic Acid + prednison for 106 weeks
| Study group | Role | What they receive |
|---|---|---|
| cyclosporine+mycophenolic acid+prednison | Experimental | Triple therapy Receives: Drug: cyclosporine +mycophenolic acid+prednison |
| mycophenolic acid + prednison | Active comparator | Mycophenolic acid+prednison 106 weeks Receives: Drug: Mycophenolic Acid + prednison |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V
Complete remission:
- Proteinuria < 0.3 g/24h
- Albumin normal
- eGFR > 60 mL/min/1.73 m2
Measured: 36 months
Secondary outcomes (4)
the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.
Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal
Measured: 36 months
the number of patients with adverse effects
Measured: 36 months
the rate (%) of decline of proteinuria in two groups
Measured: 36 months
the decrease in GFR (ml/min/1.73m2) in both groups
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: IT was impossible to find patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon, Hospital Universitario Ramon y Cajal, Hospital Infanta Sofia, Hospital Universitario Infanta Leonor, Hospital Universitario Reina Sofia de Cordoba, Hospital Regional Universitario Carlos Haya, Hospital Universitario Virgen de la Victoria, University Hospital of the Nuestra Señora de Candelaria, University of Guadalajara, Hospital San Pedro de Alcantara, Hospital Juan Canalejo
- Investigators
- Fernandez Juarez Gema, MD Ph, Study director, Hospital Universitario Fundación AlcorcónPraga Terente Manuel, MD Ph, Study chair, Hospital Universitario Doce de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299922
- Sponsor's protocol ID
- Csa-LES
- Acronym
- Csa-LES
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Open, Randomized, Parallel-group Clinical Trial, to Evaluate the Efficacy and Safety of Treatment With Prednisone, Cyclosporine, Mycophenolic Acid Versus Prednisone and Mycophenolic Acid in Lupus Nephritis Type III-IV-V.
- ClinicalTrials.gov ID
- NCT01299922
- Acronym / sponsor ID
- Csa-LES / Csa-LES
- Conditions
- Lupus Nephritis
- Keywords
- Lupus nephritis, Therapy, Cyclosporin, Mycophenolic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IT was impossible to find patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon, Hospital Universitario Ramon y Cajal, Hospital Infanta Sofia, Hospital Universitario Infanta Leonor, Hospital Universitario Reina Sofia de Cordoba, Hospital Regional Universitario Carlos Haya, Hospital Universitario Virgen de la Victoria, University Hospital of the Nuestra Señora de Candelaria, University of Guadalajara, Hospital San Pedro de Alcantara, Hospital Juan Canalejo
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Feb 2011 (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 treatment of lupus nephritis with cyclophosphamide and steroids changed the prognosis of lupus nephritis in the early '80s. In recent years, alternative regimens have appeared in both the induction and maintenance with similar results at least to those offered by the classic pattern and possibly with fewer side effects, especially for long term. The association of prednison and mycophenolate has created large expectations to that effect, and is part of first-line therapeutic arsenal of lupus nephritis type III, IV and V.
Despite the significant advances that have led to these treatments, the likelihood of complete remission after six months remains, according to the series of 8-13% and partial remission do not exceed 60% in papers published. In the last year, two articles have been published supporting the use of triple therapy (prednisone, mycophenolate, cyclosporine) in poor prognosis of lupus nephritis with hopefully better results than those obtained previously. In this study we try to compare the effectiveness of triple therapy, the therapy is now considered standard (prednisone, mycophenolate) in patients with lupus nephritis type III-IV-V
Detailed description
asd
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyclosporine+mycophenolic acid+prednison | Experimental | Drug: cyclosporine +mycophenolic acid+prednisonTriple therapy |
| mycophenolic acid + prednison | Active comparator | Drug: Mycophenolic Acid + prednisonMycophenolic acid+prednison 106 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Patients diagnosed SLE with renal type III-IV-V confirmed by renal biopsy done in the last 6 months
- Proteinuria > 2 g/24 hours and hematuria (> 5 h / field)
- MDRD4 eGFR > 60 ml/min/1.73m2
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (9 listed)
- Central nervous system LES involvement or any other vital organ
- Active infection
- Use of mycophenolic acid, mycophenolate mofetil, cyclosporine or tacrolimus in the last 6 months
- No adherence
- Women of childbearing age not using appropriate contraceptive methods.
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 |
|---|---|---|
| cyclosporine +mycophenolic acid+prednisonAlso: Triple therapyCyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks | Drug | cyclosporine+mycophenolic acid+prednison |
| Mycophenolic Acid + prednisonAlso: Conventional therapyMycophenolic Acid + prednison for 106 weeks | Drug | mycophenolic acid + prednison |
Primary outcome
the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V
Time frame: 36 months
Complete remission: * Proteinuria < 0.3 g/24h * Albumin normal * eGFR > 60 mL/min/1.73 m2
4 secondary outcomes
the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.
Time frame: 36 months
the number of patients with adverse effects
Time frame: 36 months
the rate (%) of decline of proteinuria in two groups
Time frame: 36 months
the decrease in GFR (ml/min/1.73m2) in both groups
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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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.
Fernandez Juarez Gema, MD Ph study director
Hospital Universitario Fundación Alcorcón
Praga Terente Manuel, MD Ph study chair
Hospital Universitario Doce de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclosporine +mycophenolic acid+prednison and Mycophenolic Acid + prednison in people with Lupus Nephritis, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Feb 2015. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
the number of complete remissions, between the triple therapy with cyclosporine-prednisone-mycophenolic acid and conventional therapy with mycophenolic acid-prednisone as induction therapy in patients with lupus nephritis type III-IV-V (time frame: 36 months). 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 27 Feb 2015.