A RANDOMISED CONTROL TRIAL ON ADDING DAPAGLIFLOZIN TO LUPUS NEPHRITIS TREATMENT
Phase 3
- Conditions
- Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
- Registration Number
- CTRI/2023/02/049898
- Lead Sponsor
- DR MANISH RATHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ALL NEWLY DIAGNOSED SYSTEMIC LUPUS ERYTHEMATOSUS WITH BIOPSY PROVEN LUPUS NEPHRITIS (CLASS III,IV,V,III+V,IV+V) ARE ELIGIBLE IF THEY ARE ABOVE 18 YEARS OF AGE
Exclusion Criteria
1. PATIENTS HAVING PULMONARY ALVEOLAR HEMMORHAGE
2. PATIENTS WITH NEUROPSYCHIATRIC SLE
3. PATIENT WITH RAPIDLY PROGRESSIVE RENAL FAILURE
4. PATIENTS WHO ARE ON HEMODIALYSIS
5. PATIENTS WITHH eGFR LESS THAN 25 ml/min /1.73 m2
6. PATIENTS WITH BASELINE CREATININE MORE THAN 3 mg/dl
7. PATIENTS UNWILLING TO GIVE CONSENT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TREATMENT RESPONSE AFTER 6 MONTHS AS PER KDIGO GUIDELINES WITH SERUM CREATININE , 24HOUR URINE PROTEINTimepoint: TREATMENT RESPONSE AFTER 6 months of intervention
- Secondary Outcome Measures
Name Time Method FREQUENCY OF URINARY TRACT INFECTIONS IN BOTH ARMSTimepoint: FOLLOWED UP EVERY MONTHLY FOR 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS;NUMBER OF LUPUS FLARES IN BOTH ARMSTimepoint: FOLLOWED UP EVERY MONTHLY TILL 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS;NUMBER OF SLE RELATED COMPLICATIONS AND DEATHS IN EACH ARMSTimepoint: FOLLOWED UP MONTHLY FOR 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS