Clinical Trial Treatment in Lupus Nephritis

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.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01299922

Acronym

Csa-LES

Enrollment

Registered

2011-02-21

Start date

2011-02-28

Completion date

2014-10-31

Last updated

2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Keywords

Lupus nephritis, Therapy, Cyclosporin, Mycophenolic acid

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

Detailed description

asd

Interventions

DRUGcyclosporine +mycophenolic acid+prednison

Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks

DRUGMycophenolic Acid + prednison

Mycophenolic Acid + prednison for 106 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026