Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy

Study Overview
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Brief Summary
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Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.

Official Title
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A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Diagnostic Test: PLA2R
* Diagnostic Test: TSHD7A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients who provided informed consent (2) Patients who are diagnosed as membranous nephropathy by renal biopsy (3) 18 years of age or older, male or female Exclusion Criteria: (1) identification of Secondary factors such as infectious diseases, rheumatic diseases, tumors, drugs and so on (2) Previous medicine history of immunosuppressive medication and corticosteroids (3) Patients who are not expected to complete 6 months of follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cyclophosphamide<br>Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody | Diagnostic Test: PLA2R<br>* Determination of serum concentration of anti PLA2R antibody<br>Diagnostic Test: TSHD7A<br>* Determination of serum concentration of anti TSHD7A antibody<br>|
| Cyclosporin<br>Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody | Diagnostic Test: PLA2R<br>* Determination of serum concentration of anti PLA2R antibody<br>Diagnostic Test: TSHD7A<br>* Determination of serum concentration of anti TSHD7A antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission | Urinary protein excretion<0.3 g/d (uPCR<300 mg/g or <30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal SCr. | after treatment for 6 months | 
| Partial Remission | Urinary protein excretion <3.5 g/d (uPCR <3500 mg/g or <350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable SCr. | after treatment for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated Glomerular filtration rate and serum creatinine | time to a 50% reduction in baseline estimated Glomerular filtration rate (according to CK-EPI) and to doubling of baseline creatinine | after treatment for 6 months |