CTRI/2022/01/039427尚未招募未知
EFFICACY OF PROLONGED RELEASE TACROLIMUS, ADMINISTERED ONCEDAILY, IN MAINTAINING REMISSION OF CALCINEURIN INHIBITORDEPENDENT STEROID SENSITIVE NEPHROTIC SYNDROME IN CHILDRE
All India Institute of Medical Sciences New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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. Idiopathic steroid-sensitive nephrotic syndrome
- •2. CNI dependent nephrotic syndrome, as defined by all of the following: (i) frequent relapses or
- •steroid dependence; (ii) failure of two or more immunosuppressive agents; (iii) sustained remission
- •or infrequent relapses during therapy with CNI
- •3. Therapy with oral tacrolimus twice daily for 6-30 months
- •4. Tacrolimus 12-hr trough level of 4-7 ng/mL
- •5. No or one relapse in the last 6 months
- •6. Currently in remission
- •7. Written informed consent
排除标准
- •Secondary nephrotic syndrome
- •Steroid resistant nephrotic syndrome
- •Histology other than minimal change disease, focal segmental glomerulosclerosis or
- •mesangioproliferative glomerulonephritis
- •Frequent relapses during therapy with tacrolimus
- •Therapy with either CNI for a cumulative duration of >30 months
- •Therapy with immunosuppressive agents other than prednisolone and tacrolimus in the past 6
- •months (e.g., cyclosporine, rituximab, mycophenolate mofetil or cyclophosphamide)
- •Estimated glomerular filtration rate (eGFR) less than 60 ml/min per 1.73 m2
- •Infection with hepatitis B or C or HIV
- •Seizures or recurrent headache during therapy with tacrolimus
- •Concomitant therapy with an agent that interferes with bioavailability of tacrolimus Glycosylated hemoglobin (HbA1c) >5.7% or fasting blood glucose >100 mg/dL
- •Hypomagnesemia despite therapy with magnesium oxide (<= 1.7 mg/dL)
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