Two-year follow-up study of the efficacy and safety of FK 506 in kidney transplant patients. Japanese FK 506 Study Group.
We conducted a 2-year follow-up study of the efficacy and safety of FK 506 in 104 kidney transplant patients at 32 sites in Japan. The initial daily oral dose of FK 506 was 0.3 mg/kg, which was gradually reduced to 0.15 mg/kg by month 10 and remained stable thereafter. The mean trough level of FK 506 in whole blood and the mean serum creatinine level in year 2 were 7.9 ng/ml and 1.9 mg/dl, respectively. Patient and graft survival rates for all patients were 97% and 92%, respectively. Forty-six patients (44%) experienced rejection episodes, and 84% of these episodes occurred within 3 months after transplantation. The principal adverse reactions to FK 506 therapy were hyperglycaemia, renal dysfunction and hyperkalaemia. Most of these events were dose-dependent, and disappeared or ameliorated following reduction of the FK 506 dose.
D000284:Administration, Oral; D000328:Adult; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D015996:Survival Rate; D016559:Tacrolimus / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013997:Time Factors
D007166:Immunosuppressive Agents; D011239:Prednisolone; D003404:Creatinine; D016559:Tacrolimus