Study Stopped
Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.
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
1 other identifier
observational
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 16, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2020
CompletedJune 18, 2020
February 1, 2020
2.2 years
March 16, 2018
June 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
estimated Glomerular filtration rate and serum creatinine
after treatment for 6 months
Study Arms (2)
Cyclophosphamide
Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody
Cyclosporin
Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody
Interventions
Eligibility Criteria
Patients diagnosed with Idiopathic Membranous Nephropathy
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nephrology Dept,Guangdong General Hospital
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2018
First Posted
March 23, 2018
Study Start
March 1, 2018
Primary Completion
May 10, 2020
Study Completion
May 10, 2020
Last Updated
June 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share