lupus nephritis. Systemic lupus erythematosus with organ or system involvement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Mashhad University of Medical Sciences