Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.

Detailed Description
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The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.

Official Title
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Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine
* Drug: The immunosuppressive agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of idiopathic membranous nephropathy Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g Voluntarily participated in the study and signed an informed consent Exclusion Criteria: Combined life-threatening complications such as serious infection Abnormal glucose metabolism Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc Pregnancy or breast-feeding women Undergoing other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| CR/CTR group<br>The complete remission group treated by the Comprehensive Treatment Regimen | Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine<br>* ①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day ②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily. ③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.<br>* Other names: HeiLiaoDou Particle;|
| NR/CTR group<br>The non-remission group treated by the Comprehensive Treatment Regimen | Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine<br>* ①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day ②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily. ③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.<br>* Other names: HeiLiaoDou Particle;|
| CR/IA group<br>The complete remission group treated by Immunosuppressive Agents | Drug: The immunosuppressive agents<br>* According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis<br>* Other names: Tacrolimus;|
| NR/IA group<br>The non-remission group treated by Immunosuppressive Agents. | Drug: The immunosuppressive agents<br>* According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis<br>* Other names: Tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach | Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-nucleotide-polymorphism, Traditional Chinese Medicine, the Comprehensive Treatment Regimen