Clinical Trial Treatment in Lupus Nephritis

Lupus Nephritis Clinical Trial

— Csa-LES  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01299922
• Other study ID #: Csa-LES
• Status: Withdrawn
• Phase: Phase 3
• First received: February 18, 2011
• Last updated: February 26, 2015
• Start date: February 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2011
• Source: Hospital Universitario Fundación Alcorcón
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

asd

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• cyclosporine +mycophenolic acid+prednison
Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
• Mycophenolic Acid + prednison
Mycophenolic Acid + prednison for 106 weeks

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcon	Madrid

Sponsors (13)

Lead Sponsor

Collaborator

Hospital Universitario Fundación Alcorcón

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	the number of partial and complete remissions, between triple therapy with prednisone, cyclosporine, mycophenolic acid and prednisone-mycophenolic acid.	Partial remission: Proteinuria 0.3-3.5 g/24 hours, with a decrease > 50% over basal, stable renal function and albumin normal	36 months	No
Secondary	the number of patients with adverse effects		36 months	Yes
Secondary	the rate (%) of decline of proteinuria in two groups		36 months	No
Secondary	the decrease in GFR (ml/min/1.73m2) in both groups		36 months	No