Abstract: PO1634
Randomized Clinical Study to Evaluate the Effect of Personalized Therapy on Patients with Immunoglobulin A Nephropathy (IgAN)
Session Information
- Glomerular Diseases: Treatment and Outcomes
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Schena, Francesco Paolo, Universita degli Studi di Bari Aldo Moro, Bari, Italy
- Tripepi, Giovanni, CNR-IFC, Reggio Calabria, Italy
- Abbrescia, Daniela Isabel, Fondazione Schena, Bari, Italy
- Rossini, M., Ospedale Consorziale Policlinico, Bari, Italy
- Manno, Carlo, Universita degli Studi di Bari Aldo Moro, Bari, Puglia, Italy
- L Heerspink, Hiddo Jan, Dept Clinical Pharmacy and Pharmacology, Groningen, Netherlands
Background
IgAN is the most common biopsy-proven glomerulonephritis in the world. Approximately 40% of IgAN patients reach end-stage kidney disease (ESKD) 20 years after their kidney biopsy. The high prevalence of ESKD shows that IgAN has a high economic impact in the countries because renal replacement therapy is costly. Moreover, the disease’s onset in the second and third decades of life represents a social challenge because young adult patients are very active and highly productive in the workplace. This challenge is one more reason to move from a generalized therapy for all patients to a personalized therapy.
Many randomized controlled trials (RCTs) have been conducted, stratifying IgAN patients based on the laboratory findings (serum creatinine, estimated glomerular filtration rate (eGFR) and daily proteinuria). In contrast, data from the kidney biopsy has been used only for clinical diagnosis.
Aim. We have designed a RCT to study personalized therapy in biopsy-proven IgAN patients with active and chronic renal lesions.
Methods
Our clinical study of IgAN (CLIgAN) is a multicentre, prospective, controlled and open-label randomized clinical trial based on patient’s stratification at the time of their kidney biopsy. The trial has been registered in ClinicalTrials.gov (NCT 04662723). We will consider, first, the type of renal lesions followed by serum creatinine values, eGFR and proteinuria. Primary and secondary end points have been established. Second, we will determine whether personalized therapy can slow the decline of the renal function and delay the ESKD.
Results
We will enroll 132 IgAN patients with active renal lesions (66 patients per arm) in the first RCT (ACIgAN). They will receive corticosteroids combined with renin-angiotensin system blocker (RASB) or RASB alone. Two hundred ninety-four IgAN patients with chronic renal lesions at high or very high risk of chronic kidney disease (147 patients per arm) will be enrolled in the second RCT (CHRONIgAN) in which they will receive sodium-glucose cotransporter -2 inhibitor (SGLT2-i) combined with RASB or RASB alone.
Conclusion
Using this approach we hypothesize that patients could receive personalized therapy based on renal lesions to ensure that the right drug gets to the right patient at the right time.
Funding
- Private Foundation Support