Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Multi-target maintenance therapy with Tacrolimus, Azathioprine and prednisolone combination.: Patients will receive daily Tacrolimus at a dose of 0.05-0.1 mg/kg body weight in two divid
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients 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) who was randomised to and had completed induction therapy with either Cyclophosphamide as per NIH protocol or Multi-target therapy of Tacrolimus and Azathioprine combination and had achieved either complete or partial remission with the aforesaid regimens and willing for regular treatment and follow-up. 2.Age >=18 years 3.Willingness to continue on medications, follow-up and use contraceptive measures. 4.No contraindications to any of the maintenance regimen included in the study.
Exclusion criteria
Exclusion criteria: 1.Those patients who did not achieve remission at the end of 24 weeks induction therapy. 2.Renal Biopsy at the end of induction phase showing evidence of increasing chronicity, tacrolimus nephrotoxicity or thrombotic microangiopathy. 3.Life threatening complication of Lupus particularly neurolupus during any point of study duration. 4.Contraindication to any of the therapy protocols or known hypersensitivity to treatment drugs. 5.Pregnancy and lactation. 6.Patients with advanced renal dysfunction (MDRD eGFR 7.Cases in which written informed consent is not available. 8.Patients with active life threatening infection/sepsis at onset, active viral hepatitis, HIV, any malignancy, diabetes or any contraindication for immunosuppression at any point of study duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Nephritic flare. 2.Proteinuric flare. 3.Progression to ESRD or death. 4.Rate of remission on maintenance therapy. Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Frequency and severity of adverse events. 2.Time to flare. 3.Comparison of SLEDAI-2k and renal SLEDAI in both arms. 4.Increase in 24 hours urinary protein more than 50% of baseline. 5.More than 50% reduction in eGFR. 6.Histological remission( according to activity and chronicity indices on renal biopsy) Timepoint: 12months | — |
Countries
India
Contacts
Public ContactAbhirup Bhunia
IPGMER and SSKM Hospital
Outcome results
None listed