Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01799460
• Other study ID #: ShanghaiMEC-2011
• Secondary ID: 11YZ65
• Status: Unknown status
• Phase: N/A
• First received: January 8, 2013
• Last updated: April 22, 2013
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: April 2013
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Wang Lin, PHD
• Phone: 86-13816583673
• Email: happytlynn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• The Comprehensive Treatment Regimen of Traditional Chinese Medicine
?ShenQiMoShen 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 ?HuoXueTongMai 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. ?HeiLiaoDou 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.
• The immunosuppressive agents
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis

Locations

Country	Name	City	State
China	Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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