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

G

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Terminated

Conditions

Idiopathic Membranous Nephropathy

Treatments

Diagnostic Test: TSHD7A
Diagnostic Test: PLA2R

Study type

Observational

Funder types

Other

Identifiers

NCT03475602
GDREC2017318H

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

85 participants in 2 patient groups

Cyclophosphamide
Description:
Drug: Cyclophosphamide,CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody
Treatment:
Diagnostic Test: PLA2R
Diagnostic Test: TSHD7A
Cyclosporin
Description:
Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody
Treatment:
Diagnostic Test: PLA2R
Diagnostic Test: TSHD7A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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