Health Condition 1: null- SLE with proliferative lupus nephritis Health Condition 2: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Tacrolimus Azathioprine combination: Tacrolimus is a calcineurin inhibitor and Azathioprine is antimetabolite. Both are used as immunosuppressive medication in various disorders.
Contro
Sponsors
West Bengal Government
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient with SLE as per ACR classification criteria with evidence of renal involvement with histopathological diagnosis of proliferative lupus nephritis as per ISN/RPS classification (Class III, IV, V+III and V+IV) and willing for regular treatment and follow-up. 2.Age >=18 years. 3.Completed induction therapy with any regimen before. 4.Willingness to continue on medications, follow-up and use contraceptive measures. 5.No contraindications to any of the maintenance regimen included in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with biopsy proven class IIIC/IV C. 2.Life threatening complication of Lupus (including specifically but not limited to cerebral lupus). 3.Contraindication to any of the therapy protocols or known hypersensitivity to treatment drugs. 4.Pregnancy or lactation. 5.Patients with advanced renal dysfunction (MDRD eGFR 6.Cases in which written informed consent is not available. 7.Patients with active life threatening infection/sepsis at onset, active viral hepatitis, HIV, any malignancy or any contraindication for immunosupression. 8.Renal Biopsy showing evidence of thrombotic microangiopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Induction of complete remission. 2. Partial renal remission 3. Progression to dialysis dependence Timepoint: Six months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevention of renal relapses. 2. Clinical and laboratory indices of SLE disease activity. 3. Histological results of renal biopsy: markers of activity and chronicity. 4. Rapidity of clinical response. 5. Frequency and severity of adverse effects. 6. Prevention of loss of GFR. 7. Cumulative Steroid doses in both arms Timepoint: Six months | — |
Countries
India
Contacts
Public ContactDr Atanu Pal
Outcome results
None listed