None listed
Conditions
Interventions
Intervention1: tacrolimus: 0.1 mg/kg body wt /day for 6 months
Control Intervention1: NIL: NIL
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >18 years 2.Diagnosis of SLE fulfilling four or more of the American College of Rheumatology criteria 3 Renal biopsy-proven active proliferative lupus nephritis ( Class III, IV or III+V and IV+V) within last 6 months
Exclusion criteria
Exclusion criteria: 1. Pregnancy or pt not willing for contraception 2. Male 3. Initial serum creatinine level ≥2.5mg/dl 4.Previous treatment with either CsA or tacrolimus 5.Allergy to the calcineurin inhibitors 6.Active infection 7.Receipt of cytotoxic drug (MMF/Cyclophosphamide/Azathioprine) for more than 2 weeks during the 6 months before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point of study will be the response rate at 6 months. Response will be defined by the presence of all of the three following criteria in at least two determinations one month apart ?Decrease in urine protein/creatinine ratio (P/Cr) to <3 in patients with baseline nephrotic range proteinuria or reduction of &#8805;50% in patients with subnephrotic baseline proteinuria ?Stabilization (±25%) or improvement in serum creatinine ?Absence of active urine sediment Timepoint: 6 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point of studies will be the proportion of patients who achieved complete remission at 24 weeks, defined as ?Return of serum creatinine to normal and ?Urine protein excretion of < 0.5 g/day, and ?Inactive urinary sediment (<5wbc/HPF and 5rbc/HPF and absence of red cell casts) Change in complement level (C3), anti?double-stranded DNA(dsDNA) antibody titers and serum albumin levels at 6 months. Timepoint: 6 months | — |
Countries
India
Contacts
Public Contactdr sheel bhadra jain
no
Outcome results
None listed