NephroSant has today announced enrolment of the first patient in its AQUA (Assessment of QSant for underlying allograft rejection) study. Eligible participants will have undergone kidney transplantation within 90 days of enrolment—with up to 2,000 individuals being enrolled and followed for 24 months, during which time they will be assessed for signs of acute rejection through QSant testing as well as standard-of-care diagnostics.
Minnie Sarwal, NephroSant’s founder, said: “Historically, it has been incredibly challenging to monitor the health of a kidney transplant recipient. Their alloimmunity can fluctuate rapidly, especially during the first few weeks following surgery. These fluctuations, which may signal an increasing risk of a rejection event, can be missed by a routine biopsy or may evolve into an acute event between scheduled biopsies. A test like QSant has the potential to improve long-term outcomes through the accurate prediction of rejection events.”
During the 24-month study period, the number of biopsies, rejection events and hospitalisations as well as changes in medication for each participant will be recorded, according to NephroSant. Following the conclusion of the study, these metrics will be compared to those of a retrospective, site-matched cohort of kidney transplant recipients to demonstrate QSant performance in comparison to the standard of care for detecting and facilitating early intervention of acute transplant rejection events.
Francisco Dias Lourenco, NephroSant’s senior vice president of product and operations, added: “We expect the AQUA study will provide important quantitative evidence of the benefits of QSant in terms of a reduced risk of transplant rejection and reduced reliance on invasive biopsies. We are working with investigators at over 25 centres of excellence and look forward to bringing on new sites throughout 2022.”