Clinical Trial Treatment in Lupus Nephritis (Csa-LES)

Hospital Universitario Fundación Alcorcón

Status and phase

Withdrawn

Phase 3

Conditions

Lupus Nephritis

Treatments

Drug: Mycophenolic Acid + prednison

Drug: cyclosporine +mycophenolic acid+prednison

Study type

Interventional

Funder types

Other

Identifiers

NCT01299922

Csa-LES

Details and patient eligibility

About

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

Full description

asd

Sex

All

Ages

18+ years old

Volunteers

No 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