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Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799460
Recruitment Status : Unknown
Verified April 2013 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Study Description
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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.

Condition or disease Intervention/treatment
Idiopathic Membranous Nephropathy Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine Drug: The immunosuppressive agents

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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies
Study Start Date : December 2010
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
CR/CTR group
The complete remission group treated by the Comprehensive Treatment Regimen
 Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

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.

Other Names:
  • ShenQiMoShen Decoction
  • HuoXueTongMai Capsule
  • HeiLiaoDou Particle
NR/CTR group
The non-remission group treated by the Comprehensive Treatment Regimen
 Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

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.

Other Names:
  • ShenQiMoShen Decoction
  • HuoXueTongMai Capsule
  • HeiLiaoDou Particle
CR/IA group
The complete remission group treated by Immunosuppressive Agents
 Drug: The immunosuppressive agents
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
Other Names:
  • Glucocorticoid
  • Cyclosporine
  • Cyclophosphamide
  • Tacrolimus
NR/IA group
The non-remission group treated by Immunosuppressive Agents.
 Drug: The immunosuppressive agents
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
Other Names:
  • Glucocorticoid
  • Cyclosporine
  • Cyclophosphamide
  • Tacrolimus


Outcome Measures
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Primary Outcome Measures :
  1. Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach [ Time Frame: one year ]
    Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
idiopathic membranous nephropathy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799460


Contacts
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Contact: Wang Lin, PHD 86-13816583673 happytlynn@163.com

Locations
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China, Shanghai
Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wang Lin, PHD    86-13816583673    happytlynn@163.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Study Director: Wang Lin, PHD,MD Shanghai University of Traditional Chinese Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01799460    
Other Study ID Numbers: ShanghaiMEC-2011
11YZ65 ( Other Grant/Funding Number: Shanghai Municipal Education Commission )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Shanghai University of Traditional Chinese Medicine:
single-nucleotide-polymorphism
Traditional Chinese Medicine
the Comprehensive Treatment Regimen
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Cyclosporine
Cyclophosphamide
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Glucocorticoids
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Calcineurin Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists