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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475602
Recruitment Status : Terminated (Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.)
First Posted : March 23, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Idiopathic Membranous Nephropathy Diagnostic Test: PLA2R Diagnostic Test: TSHD7A

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Study Type : Observational [Patient Registry]
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : May 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. Complete Remission [ Time Frame: 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.

  2. Partial Remission [ Time Frame: 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 :
  1. estimated Glomerular filtration rate and serum creatinine [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Idiopathic Membranous Nephropathy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475602


Locations
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China, Guangdong
Nephrology Dept,Guangdong General Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Additional Information:

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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03475602    
Other Study ID Numbers: GDREC2017318H
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases