The short-term impact of protocol biopsies in a live-related renal transplant program using tacrolimus based immunosuppression.
Guleria S, Jain S, et al.Indian Journal of Nephrology 2013; 23(4): 253-258.
Aims
To investigate the impact of protocol biopsies in live-related renal transplant programs using tacrolimus-based immunosuppression.
Interventions
Patients were administered tacrolimus (0.15mg/kg) along with either mycophenolate mofetil (500mg twice a day) or azathioprine (1.5-2mg/kg).
Participants
83 live-related renal transplant recipients with stable graft function at 1 week posttransplant.
Outcomes
The outcomes included the state of glomeruli, tubules, blood vessels, interstitium, and causes of graft dysfunction including; acute rejection, calcineurin inhibitor toxicity, acute tubular necrosis and chronic allograft nephropathy.
Follow-up
1, 6 and 12 months.
CET Conclusions
This is an interesting RCT, but of modest quality, in which recipients of living related renal transplants were randomised to either have protocol biopsies at 1,6 and 12 months or not unless clinically indicated. All patients received tacrolimus based immunosuppression, but in addition MMF or azathioprine and steroids. In the biopsy patients, subclinical rejection was noted at 1,6 and 12 months in 17.5%, 11.2% and 10% respectively, but there was a higher incidence of calcineurin inhibitor toxicity during that same period. There was no difference in renal function or in graft survival at one year and the authors conclude that protocol biopsies have a limited role in well matched living related kidney transplant patients who are receiving tacrolimus based immunosuppression. It should be noted that long term outcomes were not available and also that C4d was not examined. It should also be noted that patients with a subclinical rejection with a significant grade were given anti rejection treatment with methyl prednisolone over 3 days. Thus the authors conclusions may not be strictly accurate, as the subclinical rejection as defined at 1, 6 and 12 months, was being treated.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not reported.