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Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

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ClinicalTrials.gov Identifier: NCT01299922
Recruitment Status : Withdrawn (IT was impossible to find patients)
First Posted : February 21, 2011
Last Update Posted : February 27, 2015
Information provided by:

Study Description
Brief 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 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 or disease Intervention/treatment Phase
Lupus Nephritis Drug: cyclosporine +mycophenolic acid+prednison Drug: Mycophenolic Acid + prednison Phase 3

Detailed Description:

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : October 2014

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid. [ Time Frame: 36 months ]
    Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal

  2. the number of patients with adverse effects [ Time Frame: 36 months ]
  3. the rate (%) of decline of proteinuria in two groups [ Time Frame: 36 months ]
  4. the decrease in GFR (ml/min/1.73m2) in both groups [ Time Frame: 36 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299922

Hospital Universitario Fundación Alcorcón
Alcorcon, Madrid, Spain, 28922
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 Universitario Infanta Leonor
Hospital Universitario Reina Sofia
Hospital Regional Universitario Carlos Haya
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
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

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
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2011

Keywords provided by Hospital Universitario Fundación Alcorcón:
Lupus nephritis
Mycophenolic acid

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic