Improved renal function, with similar proteinuria, after two years of early tacrolimus withdrawal from a regimen of sirolimus plus tacrolimus.
Results at 1 year of a pilot randomized trial with 87 kidney graft recipients, comparing the maintenance treatment with sirolimus, tacrolimus and steroids (group I) versus tacrolimus withdrawal since the third month onward, followed by maintenance with SRL and steroids (group II) have shown that early elimination of tacrolimus may result in improved renal function and blood pressure control. At 2 years, 26 and 25 patients in groups I and II, respectively, were analyzed in an on-therapy and an ITT analysis. In the on-therapy analysis, group II showed lower serum creatinine (1.3+/-0.2 vs. 1.6+/-0.6 mg/dL) and lower diastolic blood pressure (74+/-9 vs. 80+/-11 mm Hg). No acute rejections occurred during the second year of follow-up. In more than 90% of patients, proteinuria was less than 1 g/d, and in 50% it was negative. In the ITT analysis, differences were found only in diastolic blood pressure (80+/-10 vs. 74+/-8 mm Hg in groups I and II respectively, P=0.009). Tacrolimus withdrawal from a combination of sirolimus and tacrolimus, in selected patients, may be observed at 2 years by an improvement in renal function and blood pressure without a higher incidence of proteinuria.
Morales
José M
JM
Nephrology Department, Hospital 12 de Octubre, Madrid, Spain. jmorales@h12o.es
Grinyó
Josep M
JM
Campistol
Josep M
JM
García-Martínez
Javier
J
Arias
Manuel
M
Paul
Javier
J
Sánchez-Fructuoso
Ana
A
Brunet
Mercé
M
Granados
Enrique
E
Munoz-Robles
Jorge A
JA
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007677:Kidney Function Tests; D010865:Pilot Projects; D011507:Proteinuria / Q000139:chemically induced / Q000453:epidemiology*; D020123:Sirolimus / Q000627:therapeutic use*; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D003404:Creatinine; D020123:Sirolimus; D016559:Tacrolimus