Abstract: FR-PO0886
Trajectories of Serum Galactose-Deficient IgA1 (Gd-IgA1) Biomarker in Patients with IgAN and Active and Chronic Renal Lesions (CLIgAN Study; Nct 0466272-2020)
Session Information
- Glomerular Outcomes: From Proteinuria to Prognosis
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Schena, Francesco Paolo, Universita degli Studi di Bari Aldo Moro, Bari, BA, Italy
- Pasculli, Emanuela, Fondazione Schena, Bari, BA, Italy
- Cox, Sharon N., Universita degli Studi di Bari Aldo Moro, Bari, BA, Italy
- Lucisano, Giuseppe, CORESEARCH Srl, Pescara, Abruzzo, Italy
- Nicolucci, Antonio, CORESEARCH Srl, Pescara, Abruzzo, Italy
Background
Gd-IgA1 is the most commonly studied biomarker in IgAN but it has not been evaluated in a prospective randomized controlled trial (RCT) in which patients received personalized therapy based on the type of kidney lesions.
Methods
We designed a longitudinal RCT in which incident IgAN patients after kidney biopsy were enrolled and randomized in four arms based on active (E1, C1) or chronic (T1,2) renal lesions. Patients with active renal lesions received immediate corticosteroid therapy combined with ACE-Is (arm A) or corticosteroids after 4 months of ACE-Is (arm B). Patients with chronic renal lesions were randomized to receive ACE-Is and after 4 months ACE-Is combined with Dapaglifozin (arm C) or ACE-Is combined with oral corticosteroids (arm D). Blood and urine samples were collected at predefined time points to evaluate serum Gd-IgA1 levels and standard outcomes (proteinuria, serum creatinine and eGFR). Sixty-five IgAN patients were included in the present study and 20 individuals were followed-up for 12 months. Serum Gd-IgA1 was measured using an enzyme-linked immunosorbent assay kit precoated with KM55 (IBL, Japan).
Results
The median Gd-IgA1 value (11257 ng/ml) in the total cohort of IgAN patients was significant higher than controls (4210 ng/ml) (p<0.001). Significantly elevated values were observed in patients with active (p< 0.04) and chronic (p< 0.001) renal lesions, compared to controls. In arm A, the trajectory of Gd-IgA1 at 12 months showed a 25% reduction from baseline. In arm B, patients receiving RASBs in the first four months showed increasing Gd-IgA1 values that reduced after corticosteroid therapy. The trajectory of Gd-IgA1 showed no reduction in IgAN patients with chronic renal lesions (arm C) and a decreasing value was observed only after corticosteroids in arm D. Daily proteinuria paralleled the trajectory of Gd-IgA1. In patients enrolled in arm A, eGFR improved by 44% compared to baseline at 12 months.
Conclusion
Corticosteroids reduced the serum levels of Gd-IgA1 in IgAN patients with active renal lesions. This biomarker showed a good prognostic value, as the reduction in Gd-IgA1 levels preceded the reduction in proteinuria.