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

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Membranous Nephropathy
• Intervention / Treatment: Diagnostic test: PLA2R; Diagnostic test: TSHD7A

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nephrology Dept,Guangdong General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Idiopathic Membranous Nephropathy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cyclophosphamide; Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody	Diagnostic test: PLA2R; Determination of serum concentration of anti PLA2R antibody; Diagnostic test: TSHD7A; Determination of serum concentration of anti TSHD7A antibody
Cyclosporin; Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody	Diagnostic test: PLA2R; Determination of serum concentration of anti PLA2R antibody; Diagnostic test: TSHD7A; Determination of serum concentration of anti TSHD7A antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): May 10, 2020
• Study Completion (Actual): May 10, 2020

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: GDREC2017318H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No