Comparison of two Steroid dose regimen in Lupus Nephritis
Phase 4
- Conditions
- Health Condition 1: null- Lupus Nephritis
- Registration Number
- CTRI/2016/01/006488
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
•With a diagnosis of SLE as per American College of Rheumatology (ACR) criteria
•Biopsy proved LN (ISN/RPS class III, IV, III+V or IV+V)
Exclusion Criteria
â??Pregnancy/lactation
â??Presence of crescents > 50% of the sampled glomeruli
â??On-going infection
â??Hepatitis B, C or human immunodeficiency virus-I/II infection
â??Prior use of steroids/ immunosuppressive medication for any indication
â??Serum creatinine > 2 mg/dl
â??Neurological or pulmonary lupus
â??History of Diabetes mellitus (DM)
â??Abnormal liver function tests
â??Drug-induced lupus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment responseTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Complete/partial remission, SELENA-SLEDAI score, QOL, serological remission and adverse events.Timepoint: 6 months