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Evaluation of the efficacy and safety of prolonged-release budesonide in children with primary IgA nephropathy.
EU CTIS ID: 2024-518759-45-00
What this study is testing
1. Proving that Budesonide DR in combination with ACEI is more effective than placebo in reducing proteinuria. 2. To assess whether treatment with Budesonide DR is better than treatment with Prednisone in reducing proteinuria in the study population.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- obtaining consent from the parent/legal guardian and the patient to participate in the study
- age 8-17 years
- primary IgA nephropathy diagnosed on kidney biopsy
- no treatment or treatment with ACEI/ARB
- steroid treatment or immunosuppressive treatment completed at least 2 months previously
- proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests
You likely can't join if
- secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease
- pregnancy or breastfeeding
- rapidly progressive glomerulonephritis in the course of IgAN
- GFR < 60 ml/min according to Schwartz at the time of randomization
- 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
- chronic diseases that, in the opinion of the researcher, may affect the course of treatment, e.g. tuberculosis
See the full eligibility criteria
- obtaining consent from the parent/legal guardian and the patient to participate in the study
- age 8-17 years
- primary IgA nephropathy diagnosed on kidney biopsy
- no treatment or treatment with ACEI/ARB
- steroid treatment or immunosuppressive treatment completed at least 2 months previously
- proteinuria >200 mg/day or protein-creatinine ratio (UPR) >0.2 g/g in three tests
- negative pregnancy test result (urine platelet) at the time of qualification to start treatment
- secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease
- pregnancy or breastfeeding
- rapidly progressive glomerulonephritis in the course of IgAN
- GFR < 60 ml/min according to Schwartz at the time of randomization
- 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
- chronic diseases that, in the opinion of the researcher, may affect the course of treatment, e.g. tuberculosis
- severe heart disease
- active peptic ulcer disease of the stomach and/or duodenum
- history of prednisone intolerance
- cataract, glaucoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.