Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

February 26, 2015 updated by: Hospital Universitario Fundación Alcorcón

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

asd

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Triple therapy
ACTIVE_COMPARATOR: mycophenolic acid + prednison
Mycophenolic acid+prednison 106 weeks
Drug: Mycophenolic Acid + prednison
Mycophenolic Acid + prednison for 106 weeks
Other Names:
  • Conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
the number of patients with adverse effects
Time Frame: 36 months
36 months
the rate (%) of decline of proteinuria in two groups
Time Frame: 36 months
36 months
the decrease in GFR (ml/min/1.73m2) in both groups
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Fundación Alcorcón

Collaborators

Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramon y Cajal
Hospital Universitario 12 de Octubre
Hospital Universitario Reina Sofia de Cordoba
Hospital Universitario Infanta Leonor
Hospital San Pedro de Alcantara
Hospital Universitario Virgen de la Victoria
University Hospital of the Nuestra Señora de Candelaria
Hospital Regional Universitario Carlos Haya
Hospital Juan Canalejo
Hospital Infanta Sofia
Hospital Universitario de Guadalajara. Spain

Investigators

  • Study Director: Fernandez Juarez Gema, MD Ph, Hospital Universitario Fundacion Alcorcon
  • Study Chair: Praga Terente Manuel, MD Ph, Hospital Universitario Doce de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

October 1, 2014

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (ESTIMATE)

February 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Csa-LES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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