budesonide for Primary IgA nephropathy

Inclusion criteria

• {"criterion_text":"- obtaining consent from the parent/legal guardian and the patient to participate in the study\n- age 8-17 years\n- primary IgA nephropathy diagnosed on kidney biopsy\n- no treatment or treatment with ACEI/ARB\n- steroid treatment or immunosuppressive treatment completed at least 2 months previously\n- proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests\n- negative pregnancy test result (urine platelet) at the time of qualification to start treatment"}

Exclusion criteria

• {"criterion_text":"- secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease\n- pregnancy or breastfeeding\n- rapidly progressive glomerulonephritis in the course of IgAN\n- GFR < 60 ml/min according to Schwartz at the time of randomization\n- currently or less than 2 months before the screenig used systemic steroid therapy or immunosuppressive treatment such as: azathioprine, mycophenolate mofetil, cyclophosphamide, tacrolimus, cyclosporine A\n- chronic diseases that, in the opinion of the researcher, may affect the course of treatment, e.g. tuberculosis\n- severe heart disease\n- active peptic ulcer disease of the stomach and/or duodenum\n- history of prednisone intolerance\n- cataract, glaucoma"}

Primary endpoints

• {"endpoint_text":"- Reduction of UPCR after 24 weeks of treatment","definition_or_measurement_approach":"Change in urine protein-creatinine ratio (UPCR) measured at baseline and after 24 weeks of treatment."}
• {"endpoint_text":"- Assessment of the percentage change in proteinuria at the end of treatment compared to the beginning of treatment","definition_or_measurement_approach":"Percentage change in proteinuria from baseline to end of treatment (measured by UPCR/proteinuria tests)."}

Secondary endpoints

• {"endpoint_text":"- Number of side effects.","definition_or_measurement_approach":"Count and classification of adverse events reported during the study period."}
• {"endpoint_text":"- Reduction in GFR during treatment","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) during treatment (Schwartz formula referenced in eligibility)."}
• {"endpoint_text":"- Reduction of UPCR after 24 weeks of treatment in relation to the beginning of treatment (deltaUPCR)","definition_or_measurement_approach":"Delta UPCR: difference in UPCR between baseline and week 24."}

Poland

Earliest CTIS Part Ii Submission Date

19-02-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

387

Number Of Sites

8

Number Of Participants

120

Primary sponsor

Full Name

Medical University Of Warsaw

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Medical Research Agency","duties_or_roles":"Source of monetary support","organisation_type":""}