Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.

Launched by FONDAZIONE SCHENA · Dec 4, 2020

Keywords

ClinConnect Summary

This clinical trial, called CLIgAN, is studying how personalized therapy can help patients with a kidney condition known as Immunoglobulin A Nephropathy (IgAN). IgAN is the most common type of kidney inflammation, and about 40% of people with this condition may develop serious kidney problems within 20 years. The goal of this study is to tailor treatments based on specific kidney damage seen in biopsy results, rather than using the same treatment for everyone. There are two groups in the trial: one will receive a type of steroid treatment, and the other will receive a different medication combined with another drug. Researchers believe that by personalizing therapy, they can better help patients manage their kidney health and delay serious complications.

To participate in this study, individuals must be adults aged 18 to 70 with a confirmed diagnosis of IgAN and specific types of kidney damage. Patients with certain other conditions or prior treatments may not qualify. Those who enroll can expect to receive specialized care and monitoring throughout the trial, which also includes a new tool to help identify patients at higher risk of kidney disease progression. Overall, this study aims to improve treatment strategies for IgAN and enhance patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.
• • IgAN patients with active or chronic or moderate renal lesions
• • Exclusion Criteria
• • Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)
• • IgAN patients with hematuria and acute renal failure
• • IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)
• • Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
• • Any prior immunosuppressive therapy
• • Superimposed IgAN in kidney transplant
• • Severe liver diseases
• • Infections
• • Malignancies
• • Pregnancy
• • Patients with myocardial infarction or cerebrovascular stroke in the previous 6 months
• • Uncontrolled diabetes
• • Aseptic necrosis of any bone
• • Other conditions that can be exacerbated by corticosteroids
• • Previous adverse side effects to RASBs
• • Previous adverse side effects to SGLT2is
• • Patients with mild renal lesions (M0,E0,S0,T0,C0), minor urinary findings, proteinuria \< 0.5 g/day, normal GFR and normal blood pressure