Evaluation of the efficacy and safety of prolonged-release budesonide in children with primary IgA nephropathy.
Key facts
- Where
- Bialystok, Cracow, Gdansk, Lublin, Poznan, Torun, Warsaw és Wroclaw, LengyelországSee the 8 sites
- Phase
- 3. fázis
Where in Lengyelország
- Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W BialymstokuBialystok, LengyelországTaking people
- Uniwersytecki Szpital Dzieciecy W KrakowieCracow, LengyelországTaking people
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországTaking people
- Uniwersytecki Szpital Dziecięcy w LublinieLublin, LengyelországTaking people
- Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W PoznaniuPoznan, LengyelországTaking people
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, LengyelországTaking people
- Medical University of WarsawWarsaw, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Warsaw
- Trial code
- EU 2024-518759-45-00
- Record updated
- 2026. március 13.
- Original description
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.Read full original descriptionShow less
SABINE - The efficacy and Safety of delayed-release Budesonide in children with primary IgA nephropathy - a multicenter, interventional phase III, randomized, placebo-controlled, double-blind study.
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.
Inclusion: 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.
Exclusion: 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; secondary forms of IgA nephropathy, e.g. nephropathy associated with IgA vasculitis (IgAVN), IgA nephropathy in the course of Crohn's disease; 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; GFR < 60 ml/min according to Schwartz at the time of randomization; pregnancy or breastfeeding; rapidly progressive glomerulonephritis in the course of IgAN; cataract, glaucoma.