Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01799460
First received: January 8, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention
Idiopathic Membranous Nephropathy
Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine
Drug: The immunosuppressive agents

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach [ Time Frame: one year ] [ Designated as safety issue: No ]
    Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799460

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

Locations
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
Study Director: Wang Lin, PHD,MD Shanghai University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01799460     History of Changes
Other Study ID Numbers: ShanghaiMEC-2011, 11YZ65
Study First Received: January 8, 2013
Last Updated: April 22, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai University of Traditional Chinese Medicine:
single-nucleotide-polymorphism
Traditional Chinese Medicine
the Comprehensive Treatment Regimen

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Glucocorticoids
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 29, 2014