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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004507-31 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly randomized controlled study.
The main objective is to evaluate the efficacy of early corticotherapy + Renin Angiotensin System (RAS) blockade or inhibitors of Sodium glucose transporter 2 (SGLT2i) (versus RAS blockade or SGLT2i alone) after two years of evolution in IgAN patients with severe histological lesions.
Currently, IgAN treatment recommendations are only based on clinico-biological parameters. Steroids therapy appears to have a major role in IgAN treatment, but previous studies evaluating steroids lacked of optimal control group and reproducible evaluation criteria. No prospective study with optimal nephroprotection had included renal pathology in patients selection criteria, although histological evaluation improves patients prognosis prediction. Until now, the lack of a reliable histological classification has precluded the use of histological lesions to evaluate IgAN prognosis and treatment. Given the recently identified major prognostic role of histological lesions in IgAN, we propose to introduce renal pathology to guide the treatment of IgAN in a multicenter study, using currently validated evaluation criteria of chronic kidney disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Active Comparator | Treatment with Renin Angiotensin system (RAS) blockade or SGLT2i. |
|
| EXPERIMENTAL | Experimental | Corticotherapy + RAS blockade or SGLT2i treatment. Drug injection (intravenous) + tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corticotherapy | Drug | 3 IV pulses steroids followed by oral steroids for 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Failure at 24 months | Failure at 24 months will be defined as :
| Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Failure at 6 months | Failure at 6 months will be defined as:
| Month 6 |
| Failure at 12 months |
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Inclusion Criteria:
Age >= 18 years
Patient with IgAN
Renal biopsy < 45 days before inclusion visit
PCR ratio >0.75 g/g (within 30 days before or after the renal biopsy)
Renal biopsy with at least 8 glomeruli, disclosing at least 2 criteria among:
Patient with Social Security Insurance or CMU
Patient having signed an informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique JOLY, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Eric ALAMARTINE | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Khalil El Karoui | Henri Mondor University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker Enfants-malades | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40627446 | Derived | Shi S, Roberts ISD, Wang Z, Jiang L, Tang C, Wang J, Lv J, Wong MG, Barbour SJ, Perkovic V, Cattran D, Zhang H; TESTING Study Pathology Group. Predictive Value of the Oxford Classification for the Effect of Glucocorticoid Therapy in IgA Nephropathy. J Am Soc Nephrol. 2026 Jan 1;37(1):150-159. doi: 10.1681/ASN.0000000796. Epub 2025 Jul 8. | |
| 37772889 |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D012084 | Renin-Angiotensin System |
| ID | Term |
|---|---|
| D008660 | Metabolism |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i) |
| Drug |
treatment with Renin angiotensin system (RAS) blockade or SGLT2i |
|
Failure at 12 months will be defined as:
|
| Month 12 |
| Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months | to compare the evolution of histological lesions between treatment groups at 12 months | Month 12 |
| Evolution of GFR at 12 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 12 months | to compare the evolution of measured GFR (mGFR) between treatment groups at 12 months (or estimated GFR (eGFR) if unavailable) | Month 12 |
| Evolution of GFR at 24 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 24 months | to compare the evolution of measured GFR (mGFR) between treatment groups at 24 months (or estimated GFR (eGFR) if unavailable) | Month 24 |
| Evolution of proteinuria assessed as : - the absolute value of proteinuria at 12 and 24 months - the absolute difference of proteinuria from baseline at 12 and 24 months | to compare the evolution of proteinuria in each group | Month 12 and 24 |
| SF36 scale at 12 months | to compare the quality of life in each therapeutic group | Month 12 |
| SF36 scale at 24 months | to compare the quality of life in each therapeutic group | Month 24 |
| Number of side effects | to assess the tolerance of treatments in each therapeutic group | Month 24 |
| Prognosis markers of failure at 24 months | Clinical, histological, and biological data (including PCR ratio, eGFR and mGFR, renal histological lesions) will be compared between patients with or without failure. | Month 24 |
| El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |