Idiopathic Membranous NephropathyNCT03475602
Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy
An observational study of Idiopathic Membranous Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- PLA2R and TSHD7A
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 10 May 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Idiopathic Membranous Nephropathy
Who may be able to join
- (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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- PLA2R, TSHD7A
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLA2RDiagnostic test
Determination of serum concentration of anti PLA2R antibody
TSHD7ADiagnostic test
Determination of serum concentration of anti TSHD7A antibody
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide | Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody Receives: Diagnostic Test: PLA2R; Diagnostic Test: TSHD7A | |
| Cyclosporin | Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody Receives: Diagnostic Test: PLA2R; Diagnostic Test: TSHD7A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: after treatment for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Mar 2018
- Primary completion10 May 2020
- Study completion10 May 2020
Why it stopped: Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475602
- Sponsor's protocol ID
- GDREC2017318H
- Status last verified
- Feb 2020
- First submitted
- 16 Mar 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT03475602
- Acronym / sponsor ID
- GDREC2017318H
- Conditions
- Idiopathic Membranous Nephropathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide | – | Diagnostic Test: PLA2R, Diagnostic Test: TSHD7ADrug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody |
| Cyclosporin | – | Diagnostic Test: PLA2R, Diagnostic Test: TSHD7ADrug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Idiopathic Membranous Nephropathy
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (3 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLA2RDetermination of serum concentration of anti PLA2R antibody | Diagnostic test | Cyclophosphamide, Cyclosporin |
| TSHD7ADetermination of serum concentration of anti TSHD7A antibody | Diagnostic test | Cyclophosphamide, Cyclosporin |
Primary outcome
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.
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.
1 secondary outcome
estimated Glomerular filtration rate and serum creatinine
Time frame: after treatment for 6 months
Results and safety
The study was stopped early (reason given: Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Membranous Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (time frame: after treatment for 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.