Health Condition 1: null- PROLIFERATIVE LUPUS NEPHRITIS
Conditions
Interventions
Intervention1: Inj.Methylprednisolone 500 mg iv OD for 3 days,
Oral TACROLIMUS 0.1mg/kg in 2 divided doses for 6 months,
Oral MYCOPHENOLATE SODIUM 1080MG-1440MG PER DAY DIVIDED IN 2-3 DOSES for 6 mon
Sponsors
IPGMER SSKM HOSPITAL KOLKATA
DR RAJENDRA PANDEY
Eligibility
Inclusion criteria
Inclusion criteria: 1. All those patients who met at least 4 of the 11 criteria for diagnosis of SLE according to the American college of rheumatology. 2. Those with histopathological diagnosis of proliferative Lupus Nephritis as per ISN/RPS classification, and willing for regular treatment and followup.
Exclusion criteria
Exclusion criteria: 1. Patients who had eGFR 2. Those who refused treatment or lost to follow up or were poorly compliant during the induction phase. 3. Those with history of allergy to macrolide antibiotics were excluded from arm II. 4. Abnormal glucose tolerance (fasting blood glucose >110 mg/dL, postprandial glucose >200 mg/dL, or hemoglobin (Hb)A1c >5.9%) were excluded from arm II. 5. Patients detected to have HIV,HEPATITIS B OR C, Malignancy,active life threatening infection at the initiation of induction will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. COMPLETE OR PARTIAL RENAL REMISSION. 2. ESRD 3. MORTALITYTimepoint: SIX MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Daily urinary protein excretion, â?¢ urinary RBC count, â?¢ serum creatinine, â?¢ anti-ds-DNA antibody, â?¢ complement C3, â?¢ systemic lupus erythematosus disease activity index (SLEDAI) â?¢ creatinine clearance, and â?¢ glucocorticoid dose. â?¢ as well as the normalization rates for PROTEINURIA urinary RBC anti-dsDNA antibody, and the complement (C3) level. Timepoint: SIX MONTHS | — |
Countries
India
Contacts
Public ContactKRISHNA PATIL
IPGMER SSKM HOSPITAL
Outcome results
None listed