We are delighted to inform you that the clinical research project led by Dr Anna Matyjek, a nephrology specialist from our team, titled “B cell depletion therapy to improve outcomes of steroid-sensitive nephrotic syndrome in adults – the BOOSTER trial,” has received funding recommendation in the second edition of the Medical Research Agency’s Head-to-Head Research Competition (ABM/2023/1). The proposal has been awarded funding in the amount of PLN 14,393,692.92, securing the seventh position in the ranking of all evaluated applications. The project is being implemented as part of a consortium led by the Medical University of Łódź, in collaboration with the Independent Public Healthcare Institution of the University Clinical Hospital No. 1 named after Norbert Barlicki of the Medical University of Łódź.
The BOOSTER clinical study is focused on patients with idiopathic steroid-sensitive nephrotic syndrome (SSNS). SSNS is a rare group of glomerular kidney diseases (ORPHA 69061), characterized by nephrotic syndrome (NS) with a sudden onset and a positive response to glucocorticoid treatment (GCS). This disease manifests in childhood and young adulthood, and its recurrence significantly impacts both the quality and length of life. Contemporary treatment involves eliminating GCS from therapeutic protocols in favour of drugs with a selective mechanism of action, prolonged effect, and a more favourable side effect profile. The primary goal of the study is to compare the effectiveness of each experimental arm against standard therapy in preventing recurrences of nephrotic syndrome in patients with SSNS.
Dr Anna Matyjek explains: “This study will provide patients with recurrent steroid-sensitive nephrotic syndrome access to the most effective known remission-sustaining therapy. As we anticipate, this will translate into an extension of the time to disease recurrence, a reduction in the use of conventional immunosuppressive drugs with a less favourable side effect profile, and an improvement in the quality of life.”
BOOSTER is a randomized head-to-head clinical study with three treatment arms, comparing the effectiveness and safety of rituximab in two alternative administration schedules (short and long) added to standard therapy versus standard therapy alone, with a total recruitment assumption of 90 patients.