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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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