Csa-LES: Clinical Trial Treatment in Lupus Nephritis

Sponsor

Hospital Universitario Fundación Alcorcón (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01299922

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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

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Study Design

Study Type:

Interventional

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 :

Feb 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Oct 1, 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 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

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

Outcome Measures

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 [36 months]
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. [36 months]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Fundación Alcorcón	Alcorcon	Madrid	Spain	28922

Investigators

Study Director: Fernandez Juarez Gema, MD Ph, Hospital Universitario Fundación Alcorcón
Study Chair: Praga Terente Manuel, MD Ph, Hospital Universitario Doce de Octubre