*Purpose: Pill burden is a limitation in kidney transplant. Tacrolimus extended-release (Astagraf XL) is a once daily formulation approved for kidney transplantation. Increased compliance could reduce or possibly modify allosensitization in HS patients and improve outcomes. Here we report on a pilot, open label, single-arm, non-controlled design study to determine safety and tolerability of Astagraf XL in HS renal transplant patients.

*Methods: All HS patients received desensitization with IVIG 2g/kg (>70kg max 140g) and rituximab 375mg/m² ± PLEX, induction with alemtuzumab and maintained with Astagraf XL, MMF, and pred taper post-tx. Monitoring parameters included BPAR, graft failure or death and AEs/SAEs @12M.

*Results: Twenty HS patients were enrolled from 9/2017-11/2019. Table 1 showed overall outcomes. Overall, 80% of patients had previous transplant, 75% had DSA at transplant, and 55% had positive FCMX with 2 patients developed dnDSA @12M post-tx. Rejections occurred in 6 patients (30%) {active/cABMR (2); chronic active CMR/ABMR (2); early TG (1) & CMR (1)} . Four patients had BK viremia. eGFR @12M was: 71±24 ml/min/1.73m². Mean tacrolimus dose @Day 365 was: 5.4±1.9mg with mean level of 8.2±3.0 (goal 5-8ng/ml). Patient and graft survival @12M were 100%. AEs included: mouth ulcer (1), perinephric fluid collection (1), BKAN grade 2 with stable Scr (1). SAEs included: bacteremia (1); DKA (1); incisional abscess & AKI (1).

*Conclusions: Astagraf XL in HS patients was safe and effective in this high risk, HS population with similar rejection rates (30%) and dnDSA generation (22%) compared to our previous experience with tacrolimus twice daily.

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