Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy

NCT ID: NCT03475602

Last Updated: 2020-06-18

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

TERMINATED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-05-10

Brief Summary

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Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.

Detailed Description

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Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cyclophosphamide

Drug: Cyclophosphamide,CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody

PLA2R

Intervention Type DIAGNOSTIC_TEST

Determination of serum concentration of anti PLA2R antibody

TSHD7A

Intervention Type DIAGNOSTIC_TEST

Determination of serum concentration of anti TSHD7A antibody

Cyclosporin

Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody

PLA2R

Intervention Type DIAGNOSTIC_TEST

Determination of serum concentration of anti PLA2R antibody

TSHD7A

Intervention Type DIAGNOSTIC_TEST

Determination of serum concentration of anti TSHD7A antibody

Interventions

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PLA2R

Determination of serum concentration of anti PLA2R antibody

Intervention Type DIAGNOSTIC_TEST

TSHD7A

Determination of serum concentration of anti TSHD7A antibody

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* (1) Patients who provided informed consent
* (2) Patients who are diagnosed as membranous nephropathy by renal biopsy
* (3) 18 years of age or older, male or female

Exclusion Criteria

* (1) identification of Secondary factors such as infectious diseases, rheumatic diseases, tumors, drugs and so on
* (2) Previous medicine history of immunosuppressive medication and corticosteroids
* (3) Patients who are not expected to complete 6 months of follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nephrology Dept,Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GDREC2017318H

Identifier Type: -

Identifier Source: org_study_id

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