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临床试验/CTRI/2019/07/020328
CTRI/2019/07/020328招募中不适用

Anti-PLA2R antibody positivity and outcome in primary membranous nephropathy- a prospective observational study

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Complete/partial remission at 6 months

研究概览

简要总结

PRIMARY PURPOSE OF STUDY:** Membranous nephropathy (MN) is one of the most common causes of nephrotic syndrome in adults. In majority of patients, it occurs in the absence of an identifiable predisposing disease (e.g. systemic lupus erythematosus {SLE}), infection (e.g. hepatitis B), drug (e.g. non-steroidal anti-inflammatory drug) or malignancy, and is termed primary. Recent evidence suggests that circulating auto-antibodies against podocyte surface antigen Anti-PLA2R and thrombospondin type 1 domain containing 7A (THSD7A) cause the disease in the majority of patients.Presently Anti PLA2R antibody titers are available for diagnosing primary membranous nephropathy. The Anti PLA2 R antibodies are positive in 70-80%% of Primary membranous nephropathy. The literature on response to therapy based on Anti PLA2 receptor antibody is lacking. So our present study would provide insight regarding the role of Anti PLA2 R antibody positivity in predicting the response to therapy and clinical outcomes in MN.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Those with biopsy proven primary membranous nephropathy.

排除标准

  • 1.Pregnancy 2.Presence of active infection 3.Evidence of secondary cause of MN (e.g. hepatitis B, SLE, drugs, malignancy) 4.Estimated GFR (eGFR) ≤ 30 mL/min/1.73m2.

结局指标

主要结局

Complete/partial remission at 6 months

时间窗: 6 months

Complete remission (CR) : Proteinuria lesser than 0.3g/day or UPCR lesser than 0.3 mg/mg, with normalization of serum albumin (more than or equal to 3.5g/dL)

时间窗: 6 months

Partial remission : Reduction of 24 hour urine protein (or UPCR) to lesser than 50% of baseline to lesser than 3.5g/day (or UPCR lesser than 3.5mg/mg), but greater than 0.3g/day (or UPCR greater than 0.3mg/mg)

时间窗: 6 months

次要结局

  • 1.Rate of eGFR decline(2.Anti-PLA2R levels at 6 and 12 months post-therapy)

研究者

发起方
未提供

研究点 (1)

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