Transplant Patients' Perceptions About Participating in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study.

Abstract

First-in-human pig xenotransplant clinical trials may soon begin, which raises ethical concerns about patients' decision-making to participate in such trials. We assessed kidney transplant candidates' attitudes and hypothetical decision-making about participating in xenotransplant trials through semi-structured telephone interviews and an online survey. We analyzed qualitative data by thematic analysis and quantitative data by descriptive statistics. Twenty-eight patients participated in interviews; 142 patients participated in the survey. Most interview and survey respondents were male (68%, 56%), White (54%, 61%), or Black (36%, 22%). Although interview participants appreciated xenotransplantation research's potential to advance science, they expressed concerns about infection transmission and graft function. Few survey respondents were willing to participate in a pig kidney trial to test the safety of pig kidneys (12.6%) or pig kidney function (16.9%). Interview participants would be more likely to participate in a first-in-human pig kidney trial if receiving a human kidney was unlikely and their health status declined. Willingness would also depend on how long the pig kidney would function. Most interview participants were receptive to long-term monitoring, but not to family monitoring. Transplant programs planning xenotransplant trials should anticipate these types of concerns for optimizing human subject protections and conducting a robust informed consent process.