Prospective randomised study comparing tacrolimus (Prograf) and cyclosporin (Neoral) as primary immunosuppression in cadaveric renal transplants at a single institution: interim report of the first 80 cases.
As part of an ongoing study, 80 patients undergoing cadaveric renal transplantation were randomised to receive either Prograf [PTT (patients receiving Prograf); n = 40]- or Neoral [NTT (patients receiving Neoral); n = 40]-based immunosuppression as part of a triple therapy regimen. Prograf was commenced at a dose of 0.2 mg/kg per day and Neoral at 8 mg/kg per day. Both groups received identical azathioprine and corticosteroid regimens. Trough levels for Prograf were maintained between 5 and 15 ng/ml and for Neoral between 100 and 200 ng/ml. During the 3-month follow up 40% of PTT and 33% of NTT experienced biopsy-proven acute rejection. In each group 81% of rejection episodes were classified as either borderline or grade 1. The median 3-month serum creatinine levels were 128 mumol/l and 135 mumol/l, respectively, for PTT and NTT. Six grafts were lost in the NTT group including three deaths with functioning grafts whilst none were lost in the PTT group (chi 2, P < 0.02). The prevalence of other complications was similar for the two groups. We conclude that Prograf represents an effective and safe therapy as a primary immunosuppressive agent following cadaveric renal transplantation and appears to have a similar side-effect profile to Neoral.
Department of Transplant Surgery, University Hospital of Wales, Cardiff, UK.
G
G
Morris-Stiff
K
K
Ostrowski
V
V
Balaji
R
R
Moore
C
C
Darby
R
R
Lord
W A
WA
Jurewicz
D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus