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Pilot Randomized Study of Early Tacrolimus Withdrawal from a Regimen with Sirolimus Plus Tacrolimus in Kidney Transplantation
Author(s) -
Grinyo Josep María,
Campistol José María,
Paul Javier,
GarcíaMartínez Javier,
Morales José María,
Prats Dolores,
Arias Manuel,
Brunet Mercedes,
Cabrera José,
Granados Enrique
Publication year - 2004
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2004.00499.x
Subject(s) - tacrolimus , medicine , sirolimus , urology , renal function , transplantation , regimen , kidney transplantation , kidney , gastroenterology , surgery
We performed a randomized trial to compare two regimens of low‐risk kidney allograft recipients in the first year after transplantation. Both regimens initially included sirolimus, tacrolimus and steroids; one with long‐term maintenance with these drugs vs. tacrolimus withdrawal. Group I: sirolimus levels of 4–8 ng/mL, plus tacrolimus 8–12 ng/mL for 3 months, and 5–10 ng/mL after month 3. Group II: sirolimus concentration of 8–16 ng/mL, plus tacrolimus 3–8 ng/mL with tacrolimus elimination from month 3 onwards. Owing to difficulties in achieving target levels, the protocol was amended to increase the doses. Eighty‐seven patients were recruited. In the intention‐to‐treat analysis, glomerular filtration rate (GFR) at 12 months, adjusted to zero for graft loss, was similar in both groups (58.8 and 59.9 mL/min). Analysis of patients remaining on protocol showed that GFR was higher in group II only in the patients postamendment (58.4 and 72.9 mL/min, p = 0.03). Rates of biopsy‐confirmed rejection (BCAR) were 9.3% and 22.7% in groups I and II, respectively (p = NS). After amendment, BCAR rates were 10.3% and 11.1% (p = NS). Diastolic blood pressure was significantly lower in patients who eliminated tacrolimus (80.4 vs. 75.6 mmHg) (p = 0.03). Combining sirolimus and tacrolimus with adequate loading doses was associated with a low incidence of BCAR, and allowed tacrolimus elimination in a high proportion of patients, which may be followed by amelioration in renal function and blood pressure.