IgA Nephropathy (IgAN)RESIGANNCT06926244
RESistance of IgA Nephropathy to Conventional and Newly-approved Therapies: an Observational, Real-life Study (RESIGAN)
An observational study of IgA Nephropathy (IgAN), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2025to Apr 2029
- 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: A total of 800 patients is expected: * Retrospective cohort: 600 patients to be expected : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from 2017 to date of start of the study * Prospective cohort: 200 participants : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from the date of start of the study : 1 to 2patients with new diagnosis/ site/month
Who may be able to join
- Adult patient: age ≥ 18 years
- Renal biopsy performed after 2017 showing IgA deposits leading to the diagnosis of IgAN (the date of diagnosis being the index date)
- Informed patient and who does not object to the use of his data
Who cannot join
- None
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
Nephrology department, Hospital Pitié - Salpêtrière (ASSISTANCE PUBLIQUE HOPITAUX DE PARIS AP-HP)
Paris, 75013
About this study
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. The prognosis varies significantly, from benign hematuria to rapidly progressive glomerulonephritis, potentially leading to end-stage renal disease within months. The MEST-C classification enhances prognosis characterization and informs integrated scoring systems; however, while useful for assessing overall prognosis, these scores do not reliably predict treatment responses and are unvalidated for IgA vasculitis nephritis. Given the disease's heterogeneity, treatment options for IgAN, with or without vasculitis, are controversial. Nephroprotective strategies that lower intraglomerular pressure through RAS blockade are essential in managing IgAN. Steroids are considered for rapidly progressive cases, yet their effectiveness in persistent proteinuria despite optimized nephroprotection is debated. Other immunosuppressive therapies, such as B cell targeting and complement inhibition, are under investigation. Recently developed nephroprotective strategies, including SGLT2 inhibitors and endothelin-1 receptor antagonists, may significantly influence future therapeutic approaches. Although available in many European countries, their real-world effectiveness has not been evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized nephroprotection is a critical unmet need. We hypothesize that innovative nephroprotective strategies will reduce the risk of persistent proteinuria and renal dysfunction in an IgAN cohort.
Read the detailed description
IgA Nephropathy (IgAN) is the most prevalent primary glomerulonephritis globally, diagnosed by detecting mesangial IgA deposits in the kidneys, often accompanied by IgG and C3. The disease's pathophysiology remains unclear despite its commonality. Prognosis can vary widely, from benign hematuria to rapidly progressive forms leading to end-stage renal disease within months. The MEST-C classification provides histological prognostic factors that enhance prognosis assessment and facilitate the development of integrated scoring systems. However, these scores are limited in predicting treatment responses and lack validation for IgA vasculitis nephritis.
Given the disease's heterogeneity, treatment strategies for IgAN are contentious. Nephroprotective approaches focusing on reducing intraglomerular pressure through RAS blockade play a significant role in management. Steroids are suggested for rapidly progressive disease, but their effectiveness in persistent proteinuria, despite optimized nephroprotection, is debated. Other treatments, including B cell-targeting therapies and complement inhibition, are under investigation. Recent advances in nephroprotection, such as SGLT2 inhibitors and endothelin-1 receptor antagonists, could significantly reshape future therapeutic strategies. While these treatments are widely available in Europe, their real-world effectiveness remains to be evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized strategies is a pressing unmet need.
This study hypothesizes that new nephroprotective strategies will influence the risk of persistent proteinuria and renal dysfunction in a real-life cohort of IgAN patients.
Primary Objective: To identify clinical, biological, and histological risk factors for persistent proteinuria and renal dysfunction in IgAN patients.
Secondary Objectives include:
Identifying risk factors for steroid therapy response. Evaluating responses to nephroprotective therapies, including SGLT2 inhibition. Analyzing responses to immunosuppressive therapies at various time points post-diagnosis.
Assessing risk factors for persistent proteinuria and renal dysfunction in patients with related conditions or IgA vasculitis.
Identifying risk factors for adverse events following nephroprotection or immunosuppressive therapies.
Describing treatment trajectories since IgAN diagnosis. Validating the International IgA Nephropathy prediction tool. Developing a cohort of IgAN patients will facilitate reliable epidemiological data collection and allow for the evaluation of responses to contemporary treatments, identifying patients with treatment resistance in real-life scenarios. This identification is critical for establishing early, efficient therapeutic strategies for IgAN patients at risk of progression.
Study Design: A prospective and retrospective observational cohort study.
Inclusion Criteria:
Adult patients aged ≥ 18 years. Renal biopsy after 2017 confirming IgA deposits for IgAN diagnosis (index date).
Informed consent from patients who do not object to data use. Non-inclusion Criteria: None.
Cohort Details:
Retrospective Cohort: Expected 600 patients, inclusion from 01/01/2017 to study start date.
Prospective Cohort: 200 participants over 2 years, followed for 2 years, totaling 4 years of research.
For retrospective data collection, information notes will be mailed to patients, allowing data use after one month without opposition. Prospective patients will receive study information during clinic visits, with data used if there is no objection. Data will be extracted from medical records, including clinical, histological, and laboratory results, collected by clinical research assistants or investigators. Patient Health Information (PHI) will be stored securely, with only month and year of birth recorded for privacy.
Analysis: For primary outcomes, univariable analysis will utilize logistic regression to explore the association of risk factors with outcomes. A multivariable model may be developed based on expert knowledge and univariable results. The model's performance will be assessed via the area under the curve (AUC) and R², with bootstrap validation to evaluate for overfitting.
Total Research Duration: 4 years, with a recruitment period of 2 years and a follow-up period of 2 years. The retrospective data will cover at least 2 years post-IgAN diagnosis, potentially extending up to 12 years based on the biopsy date (from 2017).
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- IgAN, Primary Glomerulonephritis, Mesangial IgA Deposits
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twelve months from diagnosis.
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR (Estimated Glomerular Filtration Rate) as compared to eGFR measured at baseline.
Measured: month 12 from diagnosis
Secondary outcomes (9)
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at 6 months from diagnosis
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR (Estimated Glomerular Filtration Rate) as compared to eGFR measured at baseline.
Measured: month 6 from diagnosis
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twenty-four months from diagnosis.
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR as compared to eGFR measured at baseline.
Measured: month 24 from diagnosis
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at the end of follow-up.
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR as compared to eGFR measured at baseline.
Measured: At the end of follow-up, that is at least 2 years from inclusion
Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 12, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure
Major Adverse Renal Events will be defined as the occurrence of any of the following events at the time of assessment:
- Renal failure, defined as a loss of more than 40% in eGFR as compared to the initial eGFR or eGFR <15 ml/min/1.73m2
- Dialysis
- Transplantation
Measured: month 12 from diagnosis
Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 6, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure
Major Adverse Renal Events will be defined as the occurrence of any of the following events at the time of assessment:
- Renal failure, defined as a loss of more than 40% in eGFR as compared to the initial eGFR or eGFR <15 ml/min/1.73m2
- Dialysis
- Transplantation
Measured: month 6 from diagnosis
Proportion of patients with absence of response to steroids therapy defined as persistent proteinuria or renal dysfunction at the end of steroids treatment
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR as compared to eGFR measured at baseline.
Measured: At the end of steroids treatment, that is on average at 6 months from inclusion
Proportion of patients with severe hyperkalemia (>6mM/l) evaluated at each visit
Severe hyperkalemia defined as hyperkalemia > 6mM/l
Measured: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
Proportion of patients with severe acute renal failure (KDIGO stage 3) at each visit until the end of follow-up
Acute renal failure diagnosis reaching criteria of the stage 3 of the KDIGO classification:
- Serum creatinine 3.0 times baseline
- Serum creatinine ≥ 4.0 mg/dl
- Initiation of renal replacement therapy
Measured: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
Proportion of patients with 50% decline in eGFR or end-stage kidney disease at any time during follow-up
- Loss of more than 50% in eGFR as compared to the initial eGFR
- End-stage kidney disease, defined as eGFR <15 ml/min/1.73m2
Measured: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start23 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)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
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926244
- Sponsor's protocol ID
- APHP240615
- Acronym
- RESIGAN
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESistance of IgA Nephropathy to Conventional and Newly-approved Therapies: an Observational, Real-life Study (RESIGAN)
- ClinicalTrials.gov ID
- NCT06926244
- Acronym / sponsor ID
- RESIGAN / APHP240615
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- IgAN, Primary Glomerulonephritis, Mesangial IgA Deposits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 13 Apr 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.
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. The prognosis varies significantly, from benign hematuria to rapidly progressive glomerulonephritis, potentially leading to end-stage renal disease within months. The MEST-C classification enhances prognosis characterization and informs integrated scoring systems; however, while useful for assessing overall prognosis, these scores do not reliably predict treatment responses and are unvalidated for IgA vasculitis nephritis. Given the disease's heterogeneity, treatment options for IgAN, with or without vasculitis, are controversial. Nephroprotective strategies that lower intraglomerular pressure through RAS blockade are essential in managing IgAN. Steroids are considered for rapidly progressive cases, yet their effectiveness in persistent proteinuria despite optimized nephroprotection is debated. Other immunosuppressive therapies, such as B cell targeting and complement inhibition, are under investigation. Recently developed nephroprotective strategies, including SGLT2 inhibitors and endothelin-1 receptor antagonists, may significantly influence future therapeutic approaches. Although available in many European countries, their real-world effectiveness has not been evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized nephroprotection is a critical unmet need. We hypothesize that innovative nephroprotective strategies will reduce the risk of persistent proteinuria and renal dysfunction in an IgAN cohort.
Detailed description
IgA Nephropathy (IgAN) is the most prevalent primary glomerulonephritis globally, diagnosed by detecting mesangial IgA deposits in the kidneys, often accompanied by IgG and C3. The disease's pathophysiology remains unclear despite its commonality. Prognosis can vary widely, from benign hematuria to rapidly progressive forms leading to end-stage renal disease within months. The MEST-C classification provides histological prognostic factors that enhance prognosis assessment and facilitate the development of integrated scoring systems. However, these scores are limited in predicting treatment responses and lack validation for IgA vasculitis nephritis.
Given the disease's heterogeneity, treatment strategies for IgAN are contentious. Nephroprotective approaches focusing on reducing intraglomerular pressure through RAS blockade play a significant role in management. Steroids are suggested for rapidly progressive disease, but their effectiveness in persistent proteinuria, despite optimized nephroprotection, is debated. Other treatments, including B cell-targeting therapies and complement inhibition, are under investigation. Recent advances in nephroprotection, such as SGLT2 inhibitors and endothelin-1 receptor antagonists, could significantly reshape future therapeutic strategies. While these treatments are widely available in Europe, their real-world effectiveness remains to be evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized strategies is a pressing unmet need.
This study hypothesizes that new nephroprotective strategies will influence the risk of persistent proteinuria and renal dysfunction in a real-life cohort of IgAN patients.
Primary Objective: To identify clinical, biological, and histological risk factors for persistent proteinuria and renal dysfunction in IgAN patients.
Secondary Objectives include:
Identifying risk factors for steroid therapy response. Evaluating responses to nephroprotective therapies, including SGLT2 inhibition. Analyzing responses to immunosuppressive therapies at various time points post-diagnosis.
Assessing risk factors for persistent proteinuria and renal dysfunction in patients with related conditions or IgA vasculitis.
Identifying risk factors for adverse events following nephroprotection or immunosuppressive therapies.
Describing treatment trajectories since IgAN diagnosis. Validating the International IgA Nephropathy prediction tool. Developing a cohort of IgAN patients will facilitate reliable epidemiological data collection and allow for the evaluation of responses to contemporary treatments, identifying patients with treatment resistance in real-life scenarios. This identification is critical for establishing early, efficient therapeutic strategies for IgAN patients at risk of progression.
Study Design: A prospective and retrospective observational cohort study.
Inclusion Criteria:
Adult patients aged ≥ 18 years. Renal biopsy after 2017 confirming IgA deposits for IgAN diagnosis (index date).
Informed consent from patients who do not object to data use. Non-inclusion Criteria: None.
Cohort Details:
Retrospective Cohort: Expected 600 patients, inclusion from 01/01/2017 to study start date.
Prospective Cohort: 200 participants over 2 years, followed for 2 years, totaling 4 years of research.
For retrospective data collection, information notes will be mailed to patients, allowing data use after one month without opposition. Prospective patients will receive study information during clinic visits, with data used if there is no objection. Data will be extracted from medical records, including clinical, histological, and laboratory results, collected by clinical research assistants or investigators. Patient Health Information (PHI) will be stored securely, with only month and year of birth recorded for privacy.
Analysis: For primary outcomes, univariable analysis will utilize logistic regression to explore the association of risk factors with outcomes. A multivariable model may be developed based on expert knowledge and univariable results. The model's performance will be assessed via the area under the curve (AUC) and R², with bootstrap validation to evaluate for overfitting.
Total Research Duration: 4 years, with a recruitment period of 2 years and a follow-up period of 2 years. The retrospective data will cover at least 2 years post-IgAN diagnosis, potentially extending up to 12 years based on the biopsy date (from 2017).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 800 patients is expected: * Retrospective cohort: 600 patients to be expected : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from 2017 to date of start of the study * Prospective cohort: 200 participants : Renal biopsy showing IgA deposits leading to the diagnosis of IgAN performed from the date of start of the study : 1 to 2patients with new diagnosis/ site/month
Key inclusion criteria (3 listed)
- Adult patient: age ≥ 18 years
- Renal biopsy performed after 2017 showing IgA deposits leading to the diagnosis of IgAN (the date of diagnosis being the index date)
- Informed patient and who does not object to the use of his data
Key exclusion criteria (1 listed)
- None
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
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twelve months from diagnosis.
Time frame: month 12 from diagnosis
Persistent proteinuria is defined as protein/creatinine ratio >1 g/g; renal dysfunction is defined as a loss of >20% eGFR (Estimated Glomerular Filtration Rate) as compared to eGFR measured at baseline.
9 secondary outcomes
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at 6 months from diagnosis
Time frame: month 6 from diagnosis
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twenty-four months from diagnosis.
Time frame: month 24 from diagnosis
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at the end of follow-up.
Time frame: At the end of follow-up, that is at least 2 years from inclusion
Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 12, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure
Time frame: month 12 from diagnosis
Proportion of patients experiencing a Major Adverse Renal Event (MARE) by month 6, defined as the initiation of dialysis, receipt of a kidney transplant, or onset of renal failure
Time frame: month 6 from diagnosis
Proportion of patients with absence of response to steroids therapy defined as persistent proteinuria or renal dysfunction at the end of steroids treatment
Time frame: At the end of steroids treatment, that is on average at 6 months from inclusion
Proportion of patients with severe hyperkalemia (>6mM/l) evaluated at each visit
Time frame: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
Proportion of patients with severe acute renal failure (KDIGO stage 3) at each visit until the end of follow-up
Time frame: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
Proportion of patients with 50% decline in eGFR or end-stage kidney disease at any time during follow-up
Time frame: Baseline, Month 3, Month 6, Month 12, Month 24, and then each year until the end of follow-up
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 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 IgA Nephropathy (IgAN), 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 3 inclusion and 1 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 23 Jun 2026. 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 Khalil EL KAROUI, PhD (+33 1 56 01 63 17, khalil.el-karoui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with persistent proteinuria (>1 g/g) and/or renal dysfunction (>20% eGFR decline) at twelve months from diagnosis. (time frame: month 12 from diagnosis). 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 23 Jun 2026.