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A PROJECT FOR TWO MULTICENTRE, PROSPECTIVE OPEN LABEL RANDOMIZED CLINICAL STUDIES TO EVALUATE THE EFFECT OF TARGETED THERAPY BASED ON KIDNEY BIOPSY FINDINGS IN IgAN PATIENTS (CLIgAN)
EU CTIS ID: 2024-517861-18-00
What this study is testing
To evaluate the therapeutic effect on proteinuria with early corticosteroid therapy, administered after the kidney biopsy in IgAN patients with active renal lesions (ACIgAN) versus standard care of RASBs alone followed by corticosteroids combined with RASBs; To evaluate the therapeutic effect of SGLT2i (Dapagliflozin) combined with RASBs on proteinuria versus corticosteroids combined with RASBs in patients with chronic or moderate renal lesions (CHRONIgAN); thus, to avoid the potential side effects of corticosteroid therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ACIgAN study 1. Males and females aged 18 to 75 years. 2. Written informed consent form. 3. Biopsy-proven idiopathic IgAN with active (E1 and/or C1) within 2 weeks. 4. eGFR >= 30 ml/min/1.73 m2. 5. 24 hour proteinuria >= 0.5 g. 6. Patients on treatment or candidate for the treatment with RASBs (either an ACEi or ARB), as per clinical practice, according to the current KDIGO guidelines. CHRONIgAN study 1. Males and females aged 18 to 75 years. 2. Written informed consent form. 3. Biopsy-proven idiopathic IgAN with chronic (T1,2) or moderate (M0,1, S0,1, E0, T0, C0) renal lesions at high or very high CKD risk within 4 weeks. 4. eGFR >= 30 ml/min/1.73 m2. 5. 24-hour proteinuria >= 0.5 g. 6. Patients on treatment or candidate for the treatment with RASBs (either an ACEi or ARB), as per clinical practice, according to the current KDIGO guidelines.
You likely can't join if
- 1. Non biopsy-proven IgAN 2. IgAN patients with minimal change disease at kidney biopsy and nephrotic syndrome. 3. IgAN patients with macrohematuria and acute renal failure. 4. IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 25 % of glomeruli in the kidney biopsy). 5. Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis). 6. Patients with superimposed IgAN in a kidney transplant. 7. Patients with other types of glomerular diseases 8. Patients with solitary kidney 9. Patients with end-stage kidney disease 10. Bleeding disorders not responsive to treatment 11. Patients with myocardial infarction or cerebrovascular stroke in the previous six months. 12. Severe liver diseases, infections, malignancies. 13. Uncontrolled diabetes (glycemia > 200 mg/dL and HbA1c > 7.5%). 14. Aseptic necrosis of any bone. 15. Any prior immunosuppressive therapy. 16. Other morbidities that can be exacerbated by corticosteroids. 17. Previous adverse side effects and/or contraindications to RASBs and SGLT2is. 18. Pregnancy and breastfeeding. 19. If women of childbearing potential (WOCBP): patients not available to use highly effective contraceptive measures during the study treatment period and up to one month after the last dose of study drugs.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.