Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

This study has been withdrawn prior to enrollment.
(IT was impossible to find patients)
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: February 26, 2015
Last verified: February 2011
  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:
  • 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 ] [ Designated as safety issue: No ]

    Complete remission:

    • Proteinuria < 0.3 g/24h
    • Albumin normal
    • eGFR > 60 mL/min/1.73 m2


Secondary Outcome Measures:
  • the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal

  • the number of patients with adverse effects [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • the rate (%) of decline of proteinuria in two groups [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • the decrease in GFR (ml/min/1.73m2) in both groups [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 0
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

Locations
Spain
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 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 26, 2015
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
Autoimmune Diseases
Connective Tissue Diseases
Glomerulonephritis
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Cyclosporine
Cyclosporins
Mycophenolate mofetil
Mycophenolic Acid
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015