Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy
- Conditions
- Idiopathic Membranous Nephropathy
- Interventions
- Diagnostic Test: PLA2RDiagnostic Test: TSHD7A
- Registration Number
- NCT03475602
- Lead Sponsor
- Guangdong Provincial People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
- (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
- (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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cyclosporin TSHD7A Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody Cyclophosphamide PLA2R Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody Cyclosporin PLA2R Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody Cyclophosphamide TSHD7A Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody
- Primary Outcome Measures
Name Time Method Complete Remission after treatment for 6 months 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.
Partial Remission after treatment for 6 months 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.
- Secondary Outcome Measures
Name Time Method estimated Glomerular filtration rate and serum creatinine after treatment for 6 months time to a 50% reduction in baseline estimated Glomerular filtration rate (according to CK-EPI) and to doubling of baseline creatinine
Trial Locations
- Locations (1)
Nephrology Dept,Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China