Study design and population
IgAN, proteinuria, primary IgAN
The BUDIGAN study (ISRCTN47722295, date of registration 14/02/2020) is a prospective, interventional, open-label, non-randomized study that enrolled 32 patients with IgAN, at high risk of progression. The study design is in line with our previous reportThe inclusion criteria were: age ≥ 18 years, patients with a histological diagnosis of primary IgAN, high risk of progression defined as persistent proteinuria over 1 g/day despite adequate renin–angiotensin–aldosterone system (RAAS) blockade or patients with proteinuria between 0.5 and 1 g/day after RAAS blockade if they had additional risk factors for progression (estimated glomerular filtration rate below 60 ml/min/1.73mThe study was conducted after institutional approval (The Ethics Council of Fundeni Clinical Institute, Registration number: 1975, 14th January 2020). All methods were conducted in compliance with the Declaration of Helsinki and the relevant guidelines and regulations. Informed consent was obtained from all participants or, if participants are under 16, from a parent and/or legal guardian.