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

Who is this study for? Patients with immunoglobulin A nephropathy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Idiopathic immunoglobulin A nephropathy (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 suggests the need to move from a generalized therapy for all patients to personalized therapy. Many RCTs have been conducted stratifying patients based on the laboratory findings (serum creatinine, eGFR and daily proteinuria). In contrast, data from the kidney biopsy has been used only for clinical diagnosis. Therefore, IgAN patients with active or chronic renal lesions have not been equally distributed in experimental and control arms of the randomized clinical trials (RCTs) Our clinical study of IgAN (CLIgAN) is a multicentre, prospective, controlled and open-label randomized clinical trial based on patients' stratification at the time of their kidney biopsy. The investigators will consider, first, the type of renal lesions followed by the serum creatinine values, eGFR and proteinuria. IgAN patients with active renal lesions (n=132) will be enrolled in the first RCT (ACIgAN) in which they will receive corticosteroids (pulse therapy) plus oral corticosteroids combined with RASB or RASB followed by oral corticosteroids. IgAN patients with chronic or moderate renal lesions at high or very high risk of chronic renal disease (n=294) will be enrolled in the second RCT (CHRONIgAN) in which they will receive the SGLT2 inhibitor combined with RASB compared with RASB combined with oral corticosteroids. Using this approach, the investigators 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. Recently, we developed a Clinical Decision Support System (CDSS) tool using artificial intelligence (artificial neural networks) to identify IgAN patients at high risk of developing ESKD. The IgAN tool (DialCheck) was validated in a retrospective cohort of IgAN patients but not in a prospective clinical study. The investigators propose to measure the power of the DiaCheck tool in patients enrolled in both RCTs to determine whether personalized therapy can slow the decline of the renal function to delay the ESKD. The CLIgAN study also includes a cutting-edge molecular study for precision therapy (PRECIgAN).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.

• IgAN patients with active or chronic or moderate renal lesions

Locations
Other Locations
Italy
francesco paolo Schena
RECRUITING
Bari
francesco paolo Schena
RECRUITING
Bari
Contact Information
Primary
Francesco P Schena
paolo.schena@uniba.it
3336771291
Backup
francesco P Schena
fp.schena@gmail.com
3336771291
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 878
Treatments
Experimental: Corticosteroids combined with RASBs
Patients assigned to the corticosteroid group will receive (pulse) methylprednisolone succinate 500-1000 mg/day for 3 consecutive days followed by oral prednisolone (0.5 mg/kg/bw) on alternate days until the end of month. This treatment will be repeated for three consecutive months. In addition, patients will receive RASBs that will be titrated to their maximum anti-proteinuric effect. The dose of methylprednisolone succinate will be individualized (15 mg/kg) based on the ideal body weight. In overweight and obese IgAN patients the ideal body weight will be considered. The drug will be administered in a single daily dose intravenously for 30-60 min. To avoid obesity and diabetes corticosteroids will be administered only in the morning.
Active_comparator: RASBs
Patients will receive RASBs for 3 months, titrated to their maximum anti-proteinuric effectf followed by oral corticosteroids.
Experimental: SGLT2i combined with Ramipril
IgAN patients with chronic renal lesions (T1,2) or moderate renal lesions (M0,1; S0,1; T0; E0; C0) at high or very high CKD risk (proteinuria\> 0.5 g/day and GFR \>30ml/min/1.73 m2) will receive SGLT2i combined with RASBs.
Active_comparator: Ramipril combined with corticosteroids
IgAN patients with chronic renal lesions (T1,2) or moderate renal lesions (M0,1; S0,1; T0; E0; C0) at high or very high CKD risk (proteinuria\> 0.5 g/day and GFR \>30ml/min/1.73 m2) will receive RASBs for 3 months followed by oral corticosteroids.
Sponsors
Collaborators: University of Bari
Leads: Fondazione Schena

This content was sourced from clinicaltrials.gov