A Randomized, Open-label Trial comparing efficacy of IV Cyclophosphamide, Mycophenolate mofetil or Tacrolimus as Induction Therapy in Lupus Nephrtis - NI

Indian Rheumatology Association0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1.Diagnosed with SLE according to the ACR/EULAR classification criteria 2019.
•2.Age between >=12 years.
•3.Lupus nephritis is diagnosed either clinically or biopsy-proven.
•4.Clinically: Proteinuria >= 500 mg in 24 h and/or urine routine microscopy showing active cellular casts/sediments [ >5 RBC/high power field (HPF) and >5 WBC/HPF and cellular casts]
•5.Kidney biopsy performed within the six months prior to randomization with a histological diagnosis of Class III, IV, V, or a mixture of these classes according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.
•6.All patients must give written informed consent prior to enrolment.

•1.Patients ever treated previously with CYC, MMF, TAC or steroids >15 mg/day in the last 3 months before enrolment.
•2.Patients with pre-existing chronic renal failure, previous malignancy, liver dysfunction within six months prior to randomization.
•3.Patients with previously documented severe toxicity to immunosuppressive drugs.
•4.Patients with active acute or chronic infections.
•5.Pregnancy and lactation.

发起方

Indian Rheumatology Association