*Purpose: 37 subjects have been transplanted since 2009 in a phase 2 protocol to induce tolerance in recipients of living donor renal allografts. The protocol is based upon tolerogenic CD8⁺/TCR^–facilitating cells (FCRx) and nonmyeloablative conditioning. 26 chimeric subjects have been successfully weaned from all immunosuppression (IS) for up to 8 years. All subjects taken off IS have remained off IS and none have experienced rejection.

*Methods: To study the influence of tolerance on quality of life (QoL), 13 subjects in the trial were compared with 12 subjects who would have met inclusion criteria for the FCRx tolerance protocol but were transplanted under standard of care (SoC) therapy. Subjects were administered three validated QoL self-administered questionnaires: the End Stage Renal Disease Symptom Checklist – Transplantation Module; the Short Form 36 (SF-36) questionnaire, the most frequently used patient reported outcomes instrument in clinical trials today; and the EuroQol 5 Dimension (EQ-5D-5L) questionnaire. Investigators and statisticians were blinded to the treatment group. Statistical comparisons included Fisher’s Exact test for categorical data and Student’s T-test for continuous data. Statistical significance was assessed using a two-sided alpha of 0.05.

*Results: The patient demographics were similar between the two groups (p>0.05). The ESRD-SCL-TM revealed that SoC subjects reported statistically significantly greater cardiac and renal dysfunction and significantly greater levels of side effects of corticosteroids than FCRx subjects. The General Health Component of the SF-36 showed a significant decrease in reported health among the SoC subjects. For the EQ-5D-5L, SoC subjects reported a significantly higher rate of Pain/Discomfort problems than among FCRx study subjects. A number of other domains approached statistical significance, limited by the small sample size. In summary, the three quality of life instruments used in this study were in agreement that SOC subjects reported diminished mental health in the form of greater psychological stress, decreased overall mental health, and greater anxiety/depression scores compared to the tolerant subjects. The three instruments also provided similar results in the areas of reported pain and discomfort as well as cognitive impairment, which again were notably higher in the SOC compared to the tolerant subjects.

*Conclusions: These results demonstrate that tolerance induction, allowing subjects to discontinue all IS medications, is associated with significantly improved QoL.

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