A clinical study to evaluate the effect of personalized therapy on patients with Immunoglobulin A Nephropathy, a kidney disease characterized by the accumulation of a particular type of antibodies in the kidney.

A multicentre, prospective, open-label, randomized CLinical study to evaluate the effect of personalized therapy on patients with Immunoglobulin A Nephropathy (CLIgAN) - A multicentre, prospective, open-label, randomized clinical study to evaluate the effect of personal

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006854-29-IT

Enrollment

426

Registered

2022-03-24

Start date

2022-09-28

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic IgA nephropathy (IgAN) MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females aged 18 to 75 years. 2. Written informed consent form. 3. Biopsy-proven idiopathic IgAN within 2 weeks (for patients with active renal lesions) or 4 weeks (for patients with chronic or moderate renal lesions). 4. Patients with active (E1 and/or C1) or chronic (T1,2) or moderate (M1, S1, E0, T0, C0) renal lesions at high or very high CKD risk. 5. eGFR = 30 ml/min/1.73 m2. 6. 24 hour proteinuria = 0.5 g. 7. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: 1. IgAN patients with minimal change disease at kidney biopsy and nephrotic syndrome. 2. IgAN patients with macrohematuria and acute renal failure. 3. IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 25 % of glomeruli in the kidney biopsy). 4. Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis). 5. Superimposed IgAN in a kidney transplant. 6. Patients with myocardial infarction or cerebrovascular stroke in the previous six months. 7. Severe liver diseases, infections, malignancies. 8. Uncontrolled diabetes. 9. Aseptic necrosis of any bone. 10. Any prior immunosuppressive therapy. 11. Other conditions that can be exacerbated by corticosteroids. 12. Previous adverse side effects to RASBs and SGLT2is. 13. Pregnancy and breastfeeding. 14. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: •To evaluate the effect of corticosteroids combined with RASBs in IgAN patients with active renal lesions (ACIgAN) versus RASBs alone to determine whether the renal damage is reversed by corticosteroids; •To evaluate the effect of SGLT2i (Dapagliflozin) combined with RASBs versus RASBs alone in patients with chronic renal lesions (CHRONIgAN) and in patients with moderate renal lesions at high or very high risk of CKD to determine whether a delay of the ESKD onset is achieved.;Secondary Objective: •after the prediction of ESKD through our IgAN CDSS tool (DialCheck), to determine whether personalized therapy delays the impairment of the renal function; •a cutting edge-molecular study will be conducted on a small cohort of enrolled IgAN patients with active or chronic/moderate renal lesions to evaluate the effect of precision therapy (BIO-D).;Primary end point(s): Between-arms difference in proteinuria reduction within 6 months in ACIgAN and within 12 months in CHRONIgAN study.;Timepoint(s) of evaluation of this end point: 6 months in ACIgAN study and 12 months in CHRONIgAN study.	—

Measure

Time frame

Main Objective: •To evaluate the effect of corticosteroids combined with RASBs in IgAN patients with active renal lesions (ACIgAN) versus RASBs alone to determine whether the renal damage is reversed by corticosteroids; •To evaluate the effect of SGLT2i (Dapagliflozin) combined with RASBs versus RASBs alone in patients with chronic renal lesions (CHRONIgAN) and in patients with moderate renal lesions at high or very high risk of CKD to determine whether a delay of the ESKD onset is achieved.;Secondary Objective: •after the prediction of ESKD through our IgAN CDSS tool (DialCheck), to determine whether personalized therapy delays the impairment of the renal function; •a cutting edge-molecular study will be conducted on a small cohort of enrolled IgAN patients with active or chronic/moderate renal lesions to evaluate the effect of precision therapy (BIO-D).;Primary end point(s): Between-arms difference in proteinuria reduction within 6 months in ACIgAN and within 12 months in CHRONIgAN study.;Timepoint(s) of evaluation of this end point: 6 months in ACIgAN study and 12 months in CHRONIgAN study.

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Secondary

Measure	Time frame
Secondary end point(s): • eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years); • eGFR decline > 40 % from the baseline value; • composite end point: GFR decline > 40%, ESKD (defined as long-term GFR = 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease; • absolute difference between last GFR value and baseline GFR; • stable renal function defined as a decline in GFR = 5 ml/min/1.73m2 at the end of three years follow- up; • mean annual change in the slope of the reciprocal of serum creatinine concentration; • time-averaged proteinuria (TA-P) calculated as the weighted mean of all post- randomisation measurement, with weights representing the time elapsed since the previous measurement; • proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years); • complete remission of proteinuria defined as achievement of urinary protein level = 0.2 g/day or a urinary protein-to-creatinine ratio = 0.2 g/g; • partial remission of proteinuria defined as achievement of a urinary protein level = 50% or greater compared with the baseline value.;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Secondary end point(s): • eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years); • eGFR decline > 40 % from the baseline value; • composite end point: GFR decline > 40%, ESKD (defined as long-term GFR = 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease; • absolute difference between last GFR value and baseline GFR; • stable renal function defined as a decline in GFR = 5 ml/min/1.73m2 at the end of three years follow- up; • mean annual change in the slope of the reciprocal of serum creatinine concentration; • time-averaged proteinuria (TA-P) calculated as the weighted mean of all post- randomisation measurement, with weights representing the time elapsed since the previous measurement; • proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years); • complete remission of proteinuria defined as achievement of urinary protein level = 0.2 g/day or a urinary protein-to-creatinine ratio = 0.2 g/g; • partial remission of proteinuria defined as achievement of a urinary protein level = 50% or greater compared with the baseline value.;Timepoint(s) of evaluation of this end point: 3 years

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Countries

Italy

Contacts

Public ContactClinical Operations

Clinical Research Technology S.r.l.

cligan@cr-technology.com0897724155

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026