Clinical Trial Treatment in Lupus Nephritis

NCT01299922 | Withdrawn Phase 3 DMC

• 1 other identifier: Csa-LES
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Nephritis

Keywords

Lupus nephritis; Therapy; Cyclosporin; Mycophenolic acid

Outcome Measures

Primary Outcomes (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

  Complete remission: * Proteinuria \< 0.3 g/24h * Albumin normal * eGFR \> 60 mL/min/1.73 m2

  36 months

Secondary Outcomes (4)

• the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.

  36 months

• the number of patients with adverse effects

  36 months

• the rate (%) of decline of proteinuria in two groups

  36 months

• the decrease in GFR (ml/min/1.73m2) in both groups

  36 months

Study Arms (2)

cyclosporine+mycophenolic acid+prednison

EXPERIMENTAL

Triple therapy

Drug: cyclosporine +mycophenolic acid+prednison

mycophenolic acid + prednison

ACTIVE COMPARATOR

Mycophenolic acid+prednison 106 weeks

Drug: Mycophenolic Acid + prednison

Interventions

cyclosporine +mycophenolic acid+prednison DRUG

Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks

Also known as: Triple therapy

cyclosporine+mycophenolic acid+prednison

Mycophenolic Acid + prednison DRUG

Mycophenolic Acid + prednison for 106 weeks

Also known as: Conventional therapy

mycophenolic acid + prednison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Fernandez Juarez Gema, MD Ph

  Hospital Universitario Fundación Alcorcón

  STUDY DIRECTOR

• Praga Terente Manuel, MD Ph

  Hospital Universitario Doce de Octubre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 27, 2015

Record last verified: 2011-02

Locations

ES (1)