Hôpital Necker Enfants-malades
Paris, 75015, France
NCT Number: NCT03188887
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 IV pulses steroids followed by oral steroids for 4 months
treatment with Renin angiotensin system (RAS) blockade or SGLT2i
Time frame: Month 24
Failure at 24 months will be defined as :
Time frame: Month 6
Failure at 6 months will be defined as:
Time frame: Month 12
Failure at 12 months will be defined as:
Time frame: Month 12
to compare the evolution of histological lesions between treatment groups at 12 months
Time frame: Month 12
to compare the evolution of measured GFR (mGFR) between treatment groups at 12 months (or estimated GFR (eGFR) if unavailable)
Time frame: Month 24
to compare the evolution of measured GFR (mGFR) between treatment groups at 24 months (or estimated GFR (eGFR) if unavailable)
Time frame: Month 12 and 24
to compare the evolution of proteinuria in each group
Time frame: Month 12
to compare the quality of life in each therapeutic group
Time frame: Month 24
to compare the quality of life in each therapeutic group
Time frame: Month 24
to assess the tolerance of treatments in each therapeutic group
Time frame: Month 24
Clinical, histological, and biological data (including PCR ratio, eGFR and mGFR, renal histological lesions) will be compared between patients with or without failure.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: TIGER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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