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IRCT2012071710313N1 IRCT 2013-02-04 Mashhad university of medical Sciences Efficacy of Mycophenolate Mofetil on kidney involvement in Lupus patients Efficacy of long-term Maintenance Therapy with Mycophenolate Mofetil in Lupus Nephritis 2007-12-31 anticipated 24 Complete https://irct.ir/trial/10773 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A lupus nephritis. The treatment considered as four phases for classes III and IV of lupus nephritis: 1 ) Induction: intravenous cyclophosphamide, given as boluses once a month for 3-6 consecutive months in addition to corticosteroid. 2) Maintenance: mycophenolate mofetil (to the maximum dose of 2 gr /day) combined with corticosteroid. 3) Tapering: mycophenolate mofetil dosage remaines unchanged for the first year followed by dose reduction in the second year, in the absence of relapse or partial remission fulfilment. 4) Discontinuation : if our study goals had been achieved , the mycophenolate mofetil would have been discontinued with the further tapering of prednisolone to the lowest possible dose every day or every other day and patients' follow-up for evidence of relapse. Those with class V lupus nephritis were given mycophenolate mofetil combined with corticosteroid since the diagnosis was made.
public Zahra Rezaieyazdi
Rheumatic Diseases Research Center, Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) +98 51 1801 2753 rezaieyazdiz@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Rezaieyazdi
Rheumatic Diseases Research Center, Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) +98 51 1841 0136 rezaieyazdiz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Twenty four consecutive patients with the diagnosis of lupus in accordance with ACR classification criteria were enrolled. Inclusion criteria: 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. no limit no limit Both M32.1 Systemic lupus erythematosus with organ or system involvement Treatment - Drugs The treatment considered as four phases for classes III and IV of lupus nephritis: 1 ) Induction: intravenous cyclophosphamide, given as boluses once a month for 3-6 consecutive months in addition to corticosteroid. 2) Maintenance: mycophenolate mofetil (to the maximum dose of 2 gr /day) combined with corticosteroid. 3) Tapering: mycophenolate mofetil dosage remaines unchanged for the first year followed by dose reduction in the second year, in the absence of relapse or partial remission fulfilment. 4) Discontinuation : if our study goals had been achieved , the mycophenolate mofetil would have been discontinued with the further tapering of prednisolone to the lowest possible dose every day or every other day and patients' follow-up for evidence of relapse. Those with class V lupus nephritis were given mycophenolate mofetil combined with corticosteroid since the diagnosis was made 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. 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. Mashhad university of medical Sciences Approved 2007-12-31 Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Mashhad-Iran, Tel.:(+98 511) 8412081, Fax:(+98 511)8430249, Email:ramresearch@mums.ac.ir Mashhad Iran (Islamic Republic of)