To study the effect of tacrolimus in patients with lupus nephritis
Not Applicable
- Registration Number
- CTRI/2010/091/000264
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>?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<br>?Stabilization (±25%) or improvement in serum creatinine <br>?Absence of active urine sediment<br><br>Timepoint: 6 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point of studies will be the proportion of patients who achieved complete remission at 24 weeks, defined as<br><br>?Return of serum creatinine to normal and<br>?Urine protein excretion of < 0.5 g/day, and<br>?Inactive urinary sediment (<5wbc/HPF and 5rbc/HPF and absence of red cell casts)<br><br>Change in complement level (C3), anti?double-stranded DNA(dsDNA) antibody titers and serum albumin levels at 6 months.<br>Timepoint: 6 months