A randomized trial comparing renal function in older kidney transplant patients following delayed versus immediate tacrolimus administration.
BACKGROUND
This large, randomized, multicenter trial evaluated if basiliximab induction and delayed tacrolimus can preserve renal function in older kidney transplant patients.


METHODS
Patients aged 60 years and older received delayed tacrolimus with basiliximab and mycophenolate mofetil with early steroid discontinuation (Tac-d, n=132) or standard tacrolimus with mycophenolate mofetil and steroids until day 91 (Tac-s, n=122). Tacrolimus trough levels were 5 to 10 ng/mL after day 43 in both groups. Renal function at month 6 was measured by calculated creatinine clearance (Cockcroft-Gault formula).


RESULTS
In both groups, mean recipient age was 66 years, mean donor age was 63 years with 73% of donors aged 60 years and older. Steroid discontinuation was slower than protocol specified. In the Tac-d group, 56.1% were steroid free at day 14 and 81.8% at month 6. In the Tac-s group, 37.7% were steroid free at month 4 and 63.9% at month 6. Mean (+/-SD) calculated creatinine clearance was 45.7+/-16.1 mL/min (Tac-d) and 45.0+/-18.2 mL/min (Tac-s) (P=ns), mean glomerular filtration rate (modified diet in renal disease formula) was 44.9+/-16.2 mL/min and 41.6+/-16.8 mL/min, respectively. Incidences of biopsy-proven acute rejection were 18.9% (Tac-d) and 18.0% (Tac-s). Delayed graft function was 30.3% (Tac-d) and 23.8% (Tac-s). Estimated patient survival rates (Kaplan-Meier) in the Tac-d and Tac-s groups were 96.1% vs. 99.2% and estimated graft survival rates were 90% vs. 87.6%, respectively. Safety results were similar with both regimens.


CONCLUSIONS
Delayed tacrolimus with basiliximab induction did not provide an advantage in preserving renal function or reducing delayed graft function in older kidney transplant patients.
Andrés
Amado
A
Servicio de Nefrologia, Coordinación de Transplantes, Hospital 12 de Octubre, Madrid, Spain. aandres.hdoc@salud.madrid.org
Budde
Klemens
K
Clavien
Pierre-Alain
PA
Becker
Thomas
T
Kessler
Michèle
M
Pisarski
Przemyslaw
P
Fornara
Paolo
P
Burmeister
Dirk
D
Hené
Ronald J
RJ
Cassuto-Viguier
Elisabeth
E
D000017:ABO Blood-Group System; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000368:Aged; D003404:Creatinine / Q000378:metabolism; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology / Q000502:physiology*; D008875:Middle Aged; D016559:Tacrolimus / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013997:Time Factors
D000017:ABO Blood-Group System; D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D003404:Creatinine; D016559:Tacrolimus