Comparison of maintenance therapies in proliferative lupus nephritis between tacrolimus-azathioprine-steroid combination as continuation of induction phase and azathioprine with steroid following cyclophosphamide induction.

IPGMER and SSKM Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•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 < 65 yrs.
•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.

•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 <30 ml/min/1.73m2)
•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.

发起方

IPGMER and SSKM Hospital