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

A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03475602
Enrollment
85
Registered
2018-03-23
Start date
2018-03-01
Completion date
2020-05-10
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Membranous Nephropathy

Brief summary

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.

Interventions

DIAGNOSTIC_TESTPLA2R

Determination of serum concentration of anti PLA2R antibody

DIAGNOSTIC_TESTTSHD7A

Determination of serum concentration of anti TSHD7A antibody

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Complete Remissionafter treatment for 6 monthsUrinary protein excretion\<0.3 g/d (uPCR\<300 mg/g or \<30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal SCr.
Partial Remissionafter treatment for 6 monthsUrinary protein excretion \<3.5 g/d (uPCR \<3500 mg/g or \<350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable SCr.

Secondary

MeasureTime frameDescription
estimated Glomerular filtration rate and serum creatinineafter treatment for 6 monthstime to a 50% reduction in baseline estimated Glomerular filtration rate (according to CK-EPI) and to doubling of baseline creatinine

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026