Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

• Conditions: Idiopathic Membranous Nephropathy
• Interventions: Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine; Drug: The immunosuppressive agents

• Registration Number: NCT01799460
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-02-23
• Study First Posted: 2013-02-26
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NR/CTR group	The Comprehensive Treatment Regimen of Traditional Chinese Medicine	The non-remission group treated by the Comprehensive Treatment Regimen
CR/IA group	The immunosuppressive agents	The complete remission group treated by Immunosuppressive Agents
CR/CTR group	The Comprehensive Treatment Regimen of Traditional Chinese Medicine	The complete remission group treated by the Comprehensive Treatment Regimen
NR/IA group	The immunosuppressive agents	The non-remission group treated by Immunosuppressive Agents.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China