*Purpose: As the FDA and other stakeholders in transplantation look for fit-for-purpose (FFP) patient-reported outcome measures, there is a need to better understand symptom burden after living donor kidney transplant (LDKT), and identify the best measures to capture symptoms. To examine the validity of a potential FFP measure for LDKT patients, we determined frequency and severity of symptoms on the Functional Assessment of Cancer Therapy – Kidney Symptom Index (FKSI-19), and associations with health-related quality of life (HRQOL) and graft loss.

*Methods: We examined symptoms at 3 mo and 1 year post-LDKT among 404 patients transplanted between 11/2007 and 08/2016 using the FKSI-19. The FKSI-19 includes 19 symptoms (e.g., “I feel fatigued”) rated from “not at all” to “very much” with scores from ranging from 0-76, and higher scores indicating lower symptom burden. Severe burden for individual symptoms was defined as ratings of “very much”/”quite a bit” on the FKSI-19. We examined associations between the FKSI-19 score and individual symptoms at 3 mo with 1 year post-LDKT outcomes, including: 1) HRQOL using the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS), each of which range between 0-100, with higher scores indicating higher HRQOL; 2) death censored graft survival (DCGS).

*Results: The most commonly endorsed severe symptoms on the FKSI-19 were: sleeping difficulties (21% at 3 mo and 1 year), fatigue (17% at 3 mo, 13% at 1 year), and poor appetite (15% at 3 mo, 16% at 1 year). Compared to patients with less severe symptoms, patients with severe fatigue had lower scores on the PCS: 38.8 vs. 50.2 (p<0.001; Cohen’s d = -1.25) at 1 year post-LDKT. Similarly, patients with worse appetite (49.9 vs. 54.2; p<0.001; Cohen’s d = -0.53) and more severe sleeping difficulties (49.2 vs. 54.8; p<0.001; Cohen’s d = -0.63) scored lower on the on the MCS. Patients with lower than median FKSI-19 scores at 3 mo post-LDKT had significantly lower 1 -year DCGS (plot). In addition, specific symptoms at this timepoint were associated with lower DCGS, including fatigue (91.8% vs. 97.4%, log rank p=0.03) and sleeping difficulties (90.9% vs. 97.4%, log rank p=0.02).

*Conclusions: Several individual symptoms and the FKSI-19 total score revealed suboptimal health among some LDKT recipients. Symptom severity shortly after LDKT may be good indicators of risk for 1 year graft loss. Additional research into ways the FKSI-19 can be leveraged as a FFP measure for evaluating post-LDKT health and treatment is needed.

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