Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Hospital Universitario Fundación Alcorcón.
Sponsor:
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
  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:


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:

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  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on August 28, 2014