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

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03475602
• Other study ID #: GDREC2017318H
• Status: Terminated
• Start date: March 1, 2018
• Est. completion date: May 10, 2020

Study information

• Verified date: February 2020
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Diagnostic Test:
• PLA2R
Determination of serum concentration of anti PLA2R antibody
• TSHD7A
Determination of serum concentration of anti TSHD7A antibody

Locations

Country	Name	City	State
China	Nephrology Dept,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission	Urinary 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.	after treatment for 6 months
Primary	Partial Remission	Urinary 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.	after treatment for 6 months
Secondary	estimated Glomerular filtration rate and serum creatinine	time to a 50% reduction in baseline estimated Glomerular filtration rate (according to CK-EPI) and to doubling of baseline creatinine	after treatment for 6 months