Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy

NCT ID: NCT01799460

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CR/CTR group

The complete remission group treated by the Comprehensive Treatment Regimen

The Comprehensive Treatment Regimen of Traditional Chinese Medicine

Intervention Type 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.

NR/CTR group

The non-remission group treated by the Comprehensive Treatment Regimen

The Comprehensive Treatment Regimen of Traditional Chinese Medicine

Intervention Type 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.

CR/IA group

The complete remission group treated by Immunosuppressive Agents

The immunosuppressive agents

Intervention Type DRUG

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

NR/IA group

The non-remission group treated by Immunosuppressive Agents.

The immunosuppressive agents

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

The immunosuppressive agents

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

Intervention Type DRUG

Other Intervention Names

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ShenQiMoShen Decoction HuoXueTongMai Capsule HeiLiaoDou Particle Glucocorticoid Cyclosporine Cyclophosphamide Tacrolimus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang Lin, PHD,MD

Role: STUDY_DIRECTOR

Shanghai University of Traditional Chinese Medicine

Locations

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Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wang Lin, PHD

Role: CONTACT

86-13816583673

Facility Contacts

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Wang Lin, PHD

Role: primary

86-13816583673

Other Identifiers

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11YZ65

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ShanghaiMEC-2011

Identifier Type: -

Identifier Source: org_study_id

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