Efficacy of Mycophenolate Mofetil on kidney involvement in Lupus patients

Not Applicable

Completed

• Conditions: lupus nephritis.; Systemic lupus erythematosus with organ or system involvement

• Registration Number: IRCT2012071710313N1
• Lead Sponsor: Mashhad university of medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Twenty four consecutive patients with the diagnosis of lupus in accordance with ACR classification criteria were enrolled. evidence of active proliferative glomerulonephritis in the renal biopsy (WHO class IV, III). In case of absent renal biopsy or the presence of WHO class V in biopsy, following clinical or paraclinical findings: proteinaria >1 gr/24 h (or sustained 2 to 4+ proteinuria); progressive renal failure with 30% decrease in creatinine clearance over one-year period and creatinine > 1.9 mg/dL; the presence of more than 5 red cells in HPF of urine sediment in two separate specimens taken in a year, presence of WBC, granular or hyaline casts without active infection
Exclusion criteria: WHO class I or II lupus nephritis; end stage renal disease when replacement renal therapy will be indicated, leukopenia (neutrophils < 1500/mm3) due to bone marrow suppression; recurrent episodes of bacterial infection; history of cytotoxic drug treatment for more than two weeks or pulse therapy with corticosteroids during a six-week period before study entry.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete remission. Timepoint: Patients were followed up every month during induction therapy and every other month during the first year and every 3 months thereafter during 24 month maintenance therapy. Method of measurement: a) Complete improvement of renal and extra-renal symptoms b) Return to within normal limits of ESR, C3, C4, Hb and fall of autoantibody titers c) Absence of relapses and infectious complications.

Secondary Outcome Measures

Name	Time	Method
Partial remission. Timepoint: Patients were followed up every month during induction therapy and every other month during the first year and every 3 months thereafter during 24 month maintenance therapy. Method of measurement: a) No progression of renal disease b) Regression of systemic symptoms c) Decrease of at least 50% in dysmorphic RBC, cellular casts and proteinuria or less than 1 gr proteinuria per day d) Return to within normal limits of markers of inflammation.