CTRI/2012/03/002479尚未招募3 期
A prospective, open label randomized controlled trial to compare the efficacy of oral mycophenolate mofetil (MMF) and alternate day prednisolone versus tacrolimus and alternate day prednisolone in maintaining remission in patients with idiopathic steroid resistant nephrotic syndrome - TAC-MMF
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age 1-18 years at onset of disease
- •2.Confirmed steroid resistance (initial or late resistance), defined as no response to treatment with oral prednisolone at 2 mg/kg/day for 4 weeks, in absence of significant infection
- •3.Urine protein creatinine ratio (Up/Uc) >2.0 mg/mg creatinine on first a.m. void, or 24-hr urinary protein exceeding 1 g/m2
- •4.Renal biopsy showing minimal change disease or focal segmental glomerulosclerosis (FSGS). A minimum of one glomerulus showing segmental sclerosis is required for the latter diagnosis
- •5.Informed parental consent, with willingness to follow the clinical trial protocol, including medications, future randomization, baseline and follow-up visits and procedures
排除标准
- •1.Patients with initial steroid resistance who have received treatment with immunosuppressive medications other than oral prednisolone, IV methylprednisolone or dexamethasone. Patients who have, at any time, received treatment with alkylating agents, CNI (cyclosporine, tacrolimus), azathioprine or MMF exceeding 14 days, or any IV dose of vincristine or rituximab shall be excluded.
- •2.Patients with late steroid resistance who have ever received MMF or tacrolimus exceeding 14 days; or other immunosuppressive medications in the preceding 3 months.
- •3.Patients staying more than 200 km from the Institute or those not willing to come for 2-monthly follow-up visits
- •4.Nephrotic syndrome due to diffuse mesangial sclerosis, membranous nephropathy and membranoproliferative GN
- •5.Symptomatic or asymptomatic infection with hepatitis B, C, parvovirus or human immunodeficiency virus
- •6.Secondary nephrotic syndrome, e.g., associated with above infections, post-infectious glomerulonephritis, IgA nephropathy, Henoch Schonlein purpura, systemic lupus erythematosus, vasculitis, amyloidosis, vesicoureteric reflux and Alport syndrome, medications and malignancy
- •7.Active tuberculosis. However, patients with isolated positive tuberculin test (PPD >10 mm) without clinical or radiological evidence of disease shall receive prophylaxis with INH [5 mg/kg/day for 6 months] commencing at least 2 weeks prior to enrolment
- •8.Estimated GFR <60 ml/min/1.73 m² at most recent measure prior to enrolment
- •9.Hemoglobin <9 g/dl, leukopenia (leukocytes <4000/m3), thrombocytopenia (platelets <150,000/mm3)
- •10.Known allergy to any of the study medications
- •11.History of malignancy, diabetes mellitus, organ or bone marrow transplant
研究者
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