BOOSTER trial
Project data
Project financing: 14 393 692,92 PLN, financed by the Medical Research Agency (ABM) - ABM/2023/1
Project description:
As part of the BOOSTER project, it is planned to implement a non-commercial, randomized head-to-head clinical trial, where patients will be recruited into one of 3 arms:
SoC arm – using only conventional immunosuppressive treatment
RTX-SS arm – using RTX in a short administration schedule in combination with conventional treatment
The patient group will consist of adults with idiopathic steroid-sensitive nephrotic syndrome (SSNS) with a recurrent course. SSNS is the traditional term of a group of rare glomerular diseases that manifest as nephrotic syndrome (NS).
The clinical problem is the numerous relapses and toxicity of treatment, which worsen the long-term prognosis and reduce the quality of life in this group of patients. The key aim in modern SSNS therapy is the elimination of corticosteroids and the search for selective therapies with a long duration of action and a more favorable side effect profile. Therefore, the main goal of the project is to evaluate the efficacy of the drug rituximab (RTX) in the prevention of relapse.
The research will be planned to be carried out in 7 research centers in Poland. These clinics are among the leading nephrology centers in the country and have many years of experience in the treatment of glomerular diseases.
This will be the first clinical trial in the world to compare the effectiveness of different rituximab treatment regimens in SSNS. Positive results may be crucial to advancing knowledge on optimal therapies in SSNS and formulating future recommendations for therapeutic management in this group of patients.
Beneficiary
Consortium composed of:
Medical University of Lodz (Leader)
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz (Partner)
Coordinating Principal Investigator
Anna Matyjek, MD, PhD