Trial record 9 of 102 for:
Open Studies | "Nephritis"
Clinical Trial Treatment in Lupus Nephritis (Csa-LES)
This study is currently recruiting participants.
Verified February 2011 by Hospital Universitario Fundación Alcorcón.
Sponsor:
Hospital Universitario Fundación Alcorcón.
Collaborators:
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramon y Cajal
Hospital Infanta Sofia
Hospital Infanta Leonor. Madrid. Spain
Hospital Universitario Reina Sofia
Hospital Regional Universitario Carlos Haya. Malaga. Spain
Hospital Universitario Virgen de la Victoria
University Hospital of the Nuestra Señora de Candelaria
Hospital Universitario de Guadalajara. Spain
Hospital San Pedro Alcantara. Caceres. Spain
Hospital Juan Canalejo
Information provided by:
Hospital Universitario Fundación Alcorcón.
ClinicalTrials.gov Identifier:
NCT01299922
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Drug: cyclosporine +mycophenolic acid+prednison Drug: Mycophenolic Acid + prednison |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Steroids
Drug Information available for:
Prednisone
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Hospital Universitario Fundación Alcorcón.:
Primary Outcome Measures:
- Complete remission: - Proteinuria < 0.3 g/24h - Albumin normal - eGFR > 60 mL/min/1.73 m2 [ Time Frame: 36 months ] [ Designated as safety issue: No ]To compare the efficacy, defined as 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
Secondary Outcome Measures:
- Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal [ Time Frame: 36 months ] [ Designated as safety issue: No ]To compare the efficacy, defined as the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.
- To Analyze the safety and tolerance in the two groups [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]Analyze the number of patients with adverse effects
- To Compare the development of proteinuria in two groups [ Time Frame: 36 months ] [ Designated as safety issue: No ]To compare the rate (%) of decline of proteinuria in two groups
- To compare the renal evolution in two groups [ Time Frame: 36 months ] [ Designated as safety issue: No ]To Compare the decrease in GFR (ml/min/1.73m2) in both groups
| Estimated Enrollment: | 52 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: cyclosporine+mycophenolic acid+prednison
Triple therapy
|
Drug: cyclosporine +mycophenolic acid+prednison
Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
Other Name: Triple therapy
|
|
Active Comparator: mycophenolic acid + prednison
Mycophenolic acid+prednison 106 weeks
|
Drug: Mycophenolic Acid + prednison
Mycophenolic Acid + prednison for 106 weeks
Other Name: Conventional therapy
|
Detailed Description:
asd
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299922
Contacts
| Contact: Fernandez Juárez Gema M, MD Ph | 34916219000 ext 12022 | gmfernandez@fhalcorcon.es |
Locations
| Spain | |
| Hospital Universitario Fundación Alcorcón | Recruiting |
| Alcorcon, Madrid, Spain, 28922 | |
| Contact: Fernandez Juarez Gema, MD Ph 916219000 ext 12022 gmfernandez@fhalcorcon.es | |
| Principal Investigator: Fernandez Juarez Gema, MD ph | |
Sponsors and Collaborators
Hospital Universitario Fundación Alcorcón.
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramon y Cajal
Hospital Infanta Sofia
Hospital Infanta Leonor. Madrid. Spain
Hospital Universitario Reina Sofia
Hospital Regional Universitario Carlos Haya. Malaga. Spain
Hospital Universitario Virgen de la Victoria
University Hospital of the Nuestra Señora de Candelaria
Hospital Universitario de Guadalajara. Spain
Hospital San Pedro Alcantara. Caceres. Spain
Hospital Juan Canalejo
Investigators
| Study Director: | Fernandez Juarez Gema, MD Ph | Hospital Universitario Fundación Alcorcón. |
| Study Chair: | Praga Terente Manuel, MD Ph | Hospital Universitario Doce de Octubre |
More Information
No publications provided
| Responsible Party: | Manuel Praga Terente, Hospital Universitario Doce de Octubre Madrid Spain |
| ClinicalTrials.gov Identifier: | NCT01299922 History of Changes |
| Other Study ID Numbers: | Csa-LES |
| Study First Received: | February 18, 2011 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Universitario Fundación Alcorcón.:
|
Lupus nephritis Therapy Cyclosporin Mycophenolic acid |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Cyclosporins Cyclosporine Mycophenolic Acid Mycophenolate mofetil Prednisone Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013