Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

NCT01799460 | Unknown

• 2 other identifiers: ShanghaiMEC-201111YZ65
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Membranous Nephropathy

Keywords

single-nucleotide-polymorphism; Traditional Chinese Medicine; the Comprehensive Treatment Regimen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

CR/CTR group

The complete remission group treated by the Comprehensive Treatment Regimen

Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

NR/CTR group

The non-remission group treated by the Comprehensive Treatment Regimen

Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine

CR/IA group

The complete remission group treated by Immunosuppressive Agents

Drug: The immunosuppressive agents

NR/IA group

The non-remission group treated by Immunosuppressive Agents.

Drug: The immunosuppressive agents

Interventions

The Comprehensive Treatment Regimen of Traditional Chinese Medicine DRUG

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.

Also known as: ShenQiMoShen Decoction, HuoXueTongMai Capsule, HeiLiaoDou Particle

CR/CTR group; NR/CTR group

The immunosuppressive agents DRUG

According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis

Also known as: Glucocorticoid, Cyclosporine, Cyclophosphamide, Tacrolimus

CR/IA group; NR/IA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

idiopathic membranous nephropathy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Glucocorticoids; Cyclosporine; Cyclophosphamide; Tacrolimus

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Macrolides; Lactones

Study Officials

• Wang Lin, PHD,MD

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Wang Lin, PHD

CONTACT

86-13816583673; happytlynn@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: February 26, 2013
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

CN (1)