Ten Years Follow-Up Data of Tac QD Treated Renal Transplant Patients.

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Introduction Tacrolimus is used since the mid 90's as Tac BID. In 2003, 40 renal transplant patients (RTx) participated in a phase 2 PK study on conversion (conv) from Tac BID to Tac QD (ADVAGRAF). Main inclusion criteria were: adult Rtx on TAC BID > 6 months, stable creatinine < 265 umol/L. After the study, 39 RTx participated in the followup study with Tac QD compassionate use. We describe their 10-yr clinical data. Methods: Data were collected from patient files (number or median + range). Results: Two RTx restared Tac BID <4 months after conv (increased liver enzymes and dizziness) and were excluded from analysis. Characteristics of the 37 included RTx were: Recipient: Male 25 (68%); Orig disease: Immunologic 16 (IgA 7), PCKD 9, Other 7, Urologic 3, Cardiovascular: 2. Tx: 1st-tx 30 (81%), re-Tx 7. Donor: living 11, DBD 17, DCD 9. Donor age 45,0 (range 15-69) yr. Conversion: 4.1 years postTx (1.5-11.4). Age RTx 55.3 yr (range 20-64); Tacro monotherapy 29 (78%), Dual 8 (MMF 5, Pred 3). 3 RTx were censored at FU because of switch to 1. Sirolimus at 2 yr (recurrent skin cancers); restarted later Tac BID (Sirolimus intolerance). 2. Tac BID at 3 yr (local doctor; unclear safety concerns), restarted Tac QD. Both have good graft function 14 resp. 15 yr postTx; 3. Withdrawn at yr 4 (non-compliant for scheduled visits), restarted Tac BID. Graft failed 6 yr later (13 yr postTx Bx proven chron hum rej). 34 RTx (89%) continued Tac QD during the 10 yr FU. Pat Surv:92% and 85% at 5 and 10 yr postconv. Five patients died with functioning graft (1.2 - 9.2 year postconv due to cardiovascular (2x), pulm adenocarc, pulm embolism, Creutzfeldt-Jakob). Death-cens Graft Surv:100% and 83% at 5 and 10 year postconv. 5 graft losses (8.2- 9.0 yr postconv) due to Bx proven recurr IgA (3x), chronic rej (no Bx), ESRD after cardiac surgery. There were no acute rejections during follow-up. Creatinine at conv 128 umol/L (64-180), at 10 yr 141 umol/L (66-304). Conclusion: Although an observational study, it shows excellent Graft Survival, Patient Survival, and renal function during 10 year follow up on Tac QD with 78% TAC QD monotherapy! Graft failures were mainly due to recurrent disease (high rate of recurrent IgA!) with only 1 (chronic) allograft rejection. DISCLOSURES:Christiaans, M.: Grant/Research Support, Investigator contracted research, Speaker's Bureau, Speaker. van Hooff, J.: Speaker's Bureau, Speaker.

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