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TerminatedNCT03475602Updated Jun 18, 2020

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

An observational study in Idiopathic Membranous Nephropathy, sponsored by Guangdong Provincial People's Hospital. Terminated at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by Guangdong Provincial People's Hospital · Observational

Why this study was terminated
Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Idiopathic Membranous Nephropathy
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In context

Glomerulonephritis, Membranous

119 studies on the registry are indexed under Glomerulonephritis, Membranous; 40 are open to participants now.

This study's enrollment of 85 is below the median of 104 across 33 observational studies indexed under Glomerulonephritis, Membranous.

Browse Glomerulonephritis, Membranous studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients diagnosed with Idiopathic Membranous Nephropathy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Cyclophosphamide

    Drug: Cyclophosphamide,CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody

    Diagnostic Test: PLA2R · Diagnostic Test: TSHD7A

  • Cyclosporin

    Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody

    Diagnostic Test: PLA2R · Diagnostic Test: TSHD7A

Interventions

  • Diagnostic testPLA2R

    Determination of serum concentration of anti PLA2R antibody

  • Diagnostic testTSHD7A

    Determination of serum concentration of anti TSHD7A antibody

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: after treatment for 6 months

  2. 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.

    Time frame: after treatment for 6 months

Secondary outcomes

  1. 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

    Time frame: after treatment for 6 months

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Study locations

1 site
  • Nephrology Dept,Guangdong General Hospital
    Guangzhou, Guangdong, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03475602
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Mar 1, 2018
Primary completion
May 10, 2020
Completion
May 10, 2020
Last update
Jun 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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