Idiopathic Nephrotic Syndrome (INS)DNI-SNINCT06820866
Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes
An observational study of Idiopathic Nephrotic Syndrome (INS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Renal biopsy (RB) is the reference diagnostic procedure for Idiopathic Nephrotic Syndrome (INS). It is an invasive procedure, particularly risky during the acute phase of nephrotic syndrome when anticoagulation therapy is required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Nephrotic Syndrome (INS)
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The diagnostic management of pediatric nephrotic syndrome is already covered by specific guidelines. Therefore, the population of our study will consist of adults over 18 years of age presenting with a first episode of nephrotic syndrome, without detectable anti-PLA2r antibodies in the serum (since their presence indicates the diagnosis of MN), and for whom a renal biopsy is indicated and performed for diagnostic purposes
Who may be able to join
- Patients aged 18 years and older
- Hospitalized for a first episode of nephrotic syndrome (proteinuria greater than 3g/g and albumin level < 30g/L)
- Negative anti-PLA2r antibodies in the blood
- Requirement for a renal biopsy for diagnostic purposes
Who cannot join
- Patients with known lupus nephropathy (prior to the current episode)
- Patients with known IgA nephropathy (prior to the current episode)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Dialyses, Hôpital Tenon
Paris, France, 75020
Alexandre LAHENS, Dr, +33 1 56 01 70 43, alexandre.lahens@aphp.fr
Jean-Jacques BOFFA, Pr, +33 1 56 01 60 29, jean-jacques.boffa@aphp.fr
About this study
Official title: Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes : DNI-SNI
Renal biopsy (RB) is the reference diagnostic procedure for Idiopathic Nephrotic Syndrome (INS). It is an invasive procedure, particularly risky during the acute phase of nephrotic syndrome when anticoagulation therapy is required.
By identifying serum antibodies that allow for the non-invasive diagnosis of the main differential diagnoses of INS, (Membranous Nephropathy), the development of a non-invasive diagnostic tool for INS could help reduce the morbidity associated with the invasive renal biopsy procedure, minimizing the risk of incorrect diagnosis. We developed a diagnostic score, the SNIT, from routine clinical and biological variables to allow INS diagnoses in patients for whom detection of blood antibodies of Membranous Nephropathy were negative. The main goal of this study is to validate this diagnosis score in a prospective study, to allow INS diagnosis without renal biopsy.
Read the detailed description
Medical management will not be altered by the protocol, and patients will be treated according to the practices of each center.
The investigator will offer participation in the study to all eligible consecutive patients in their center. They will provide an information sheet and answer any questions the patient may have. After obtaining the patient's non-opposition, the following clinical and biological data will be collected:
(Age, sex, medical and surgical history, BMI at admission, systolic and diastolic blood pressure at admission, presence of lower limb edema, CBC, blood electrolyte levels, urea, creatinine, albumin levels, urinary electrolytes, proteinuria, albuminuria, urine culture, antinuclear antibodies, serum protein electrophoresis, serum protein immunofixation, complement fractions C3 and C4, lipid profile).
The SNIT calculation will be performed automatically in the CRF from the variables it comprises, but will not be visible to the investigator.
As part of patient care, patients will be followed up one month after inclusion. During this visit, the evolving biological data (creatinine, albumin levels, proteinuria, albuminuria) and the treatment administered will be collected from the patient's medical records.
The final diagnosis will be collected as soon as it is available (within a maximum of 4 months for the completion and reporting of the histopathological results). Histological data will be collected from the report of the pathologist who examined the renal biopsy (available in the medical record). (In the case of INS: presence or absence of segmental and focal hyalinosis lesions, percentage of fibrosis).
The objectives of this study will be :
- Evaluate the diagnostic performance of SNIT compared to renal biopsy (reference examination) for the diagnosis of Idiopathic Nephrotic Syndrome (INS)
- Evaluate the other diagnostic parameters of the SNIT test.
- Evaluate the avoidable costs
- Evaluate the theoretical risks of a misdiagnosis of INS (through diagnostic delay and its consequences, as well as the risk of unnecessary corticosteroid treatment).
Duration of participant involvement and study duration:
The inclusion period will be 24 months. The follow-up period for participants will be a maximum of 4 months (until the histological diagnosis is returned). Therefore, the total duration of the research will be a maximum of 28 months.
- Conditions
- Idiopathic Nephrotic Syndrome (INS)
- Keywords
- Kidney disease, Creatinine, DNI-SNI, Renal disease, Nephrotic Syndromes, Renal biopsy, Diagnostic score, Idiopathic Nephrotic Syndromes
- Medical subject headings
- Nephrosis, Lipoid, Kidney Diseases, Nephrotic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the SNIT score (threshold = 0.36) and their 95% confidence interval
Measured: 4 months
Secondary outcomes (3)
Proportion of biopsies avoided with the use of SNIT. Proportions of diagnostic errors. Negative and positive predictive values and likelihood ratios of SNIT.
Measured: 4 months
Avoidable costs: costs of biopsies, impact on nephrology services.
Measured: 4 months
Estimation of the number of hospitalization days with the use of SNIT, and comparison with the actual number of hospitalization days.
The theoretical number of hospitalization days with the use of SNIT (i.e., estimated from the CRH data, subtracting the days of hospitalization required for renal biopsy in the case of a positive test).
Adverse effects of corticosteroid treatment: infections, edema syndrome, corticosteroid-induced diabetes, heart failure decompensation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start15 Apr 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Nephrotic Syndrome (INS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre LAHENS, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820866
- Sponsor's protocol ID
- APHP241612
- Other IDs
- 2024-A02829-38
- Acronym
- DNI-SNI
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2025
- Last updated
- 14 Aug 2025
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes : DNI-SNI
- ClinicalTrials.gov ID
- NCT06820866
- Acronym / sponsor ID
- DNI-SNI / APHP241612
- Conditions
- Idiopathic Nephrotic Syndrome (INS)
- Keywords
- Kidney disease, Creatinine, DNI-SNI, Renal disease, Nephrotic Syndromes, Renal biopsy, Diagnostic score, Idiopathic Nephrotic Syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Feb 2025 (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.
Renal biopsy (RB) is the reference diagnostic procedure for Idiopathic Nephrotic Syndrome (INS). It is an invasive procedure, particularly risky during the acute phase of nephrotic syndrome when anticoagulation therapy is required.
By identifying serum antibodies that allow for the non-invasive diagnosis of the main differential diagnoses of INS, (Membranous Nephropathy), the development of a non-invasive diagnostic tool for INS could help reduce the morbidity associated with the invasive renal biopsy procedure, minimizing the risk of incorrect diagnosis. We developed a diagnostic score, the SNIT, from routine clinical and biological variables to allow INS diagnoses in patients for whom detection of blood antibodies of Membranous Nephropathy were negative. The main goal of this study is to validate this diagnosis score in a prospective study, to allow INS diagnosis without renal biopsy.
Detailed description
Medical management will not be altered by the protocol, and patients will be treated according to the practices of each center.
The investigator will offer participation in the study to all eligible consecutive patients in their center. They will provide an information sheet and answer any questions the patient may have. After obtaining the patient's non-opposition, the following clinical and biological data will be collected:
(Age, sex, medical and surgical history, BMI at admission, systolic and diastolic blood pressure at admission, presence of lower limb edema, CBC, blood electrolyte levels, urea, creatinine, albumin levels, urinary electrolytes, proteinuria, albuminuria, urine culture, antinuclear antibodies, serum protein electrophoresis, serum protein immunofixation, complement fractions C3 and C4, lipid profile).
The SNIT calculation will be performed automatically in the CRF from the variables it comprises, but will not be visible to the investigator.
As part of patient care, patients will be followed up one month after inclusion. During this visit, the evolving biological data (creatinine, albumin levels, proteinuria, albuminuria) and the treatment administered will be collected from the patient's medical records.
The final diagnosis will be collected as soon as it is available (within a maximum of 4 months for the completion and reporting of the histopathological results). Histological data will be collected from the report of the pathologist who examined the renal biopsy (available in the medical record). (In the case of INS: presence or absence of segmental and focal hyalinosis lesions, percentage of fibrosis).
The objectives of this study will be :
- Evaluate the diagnostic performance of SNIT compared to renal biopsy (reference examination) for the diagnosis of Idiopathic Nephrotic Syndrome (INS)
- Evaluate the other diagnostic parameters of the SNIT test.
- Evaluate the avoidable costs
- Evaluate the theoretical risks of a misdiagnosis of INS (through diagnostic delay and its consequences, as well as the risk of unnecessary corticosteroid treatment).
Duration of participant involvement and study duration:
The inclusion period will be 24 months. The follow-up period for participants will be a maximum of 4 months (until the histological diagnosis is returned). Therefore, the total duration of the research will be a maximum of 28 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The diagnostic management of pediatric nephrotic syndrome is already covered by specific guidelines. Therefore, the population of our study will consist of adults over 18 years of age presenting with a first episode of nephrotic syndrome, without detectable anti-PLA2r antibodies in the serum (since their presence indicates the diagnosis of MN), and for whom a renal biopsy is indicated and performed for diagnostic purposes
Key inclusion criteria (4 listed)
- Patients aged 18 years and older
- Hospitalized for a first episode of nephrotic syndrome (proteinuria greater than 3g/g and albumin level < 30g/L)
- Negative anti-PLA2r antibodies in the blood
- Requirement for a renal biopsy for diagnostic purposes
Key exclusion criteria (2 listed)
- Patients with known lupus nephropathy (prior to the current episode)
- Patients with known IgA nephropathy (prior to the current episode)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity and specificity of the SNIT score (threshold = 0.36) and their 95% confidence interval
Time frame: 4 months
3 secondary outcomes
Proportion of biopsies avoided with the use of SNIT. Proportions of diagnostic errors. Negative and positive predictive values and likelihood ratios of SNIT.
Time frame: 4 months
Avoidable costs: costs of biopsies, impact on nephrology services.
Time frame: 4 months
Estimation of the number of hospitalization days with the use of SNIT, and comparison with the actual number of hospitalization days.
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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.
Alexandre LAHENS, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
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 Nephrotic Syndrome (INS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre LAHENS, Dr (+33 1 56 01 70 43, alexandre.lahens@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the SNIT score (threshold = 0.36) and their 95% confidence interval (time frame: 4 months). 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 14 Aug 2025.