Background/Aims: 1,25-Dihydroxyvitamin D3 (1,25-(OH)2D3) plays an important role in regulating immunologic responsiveness in addition to its effects on bone metabolism. This is potentially beneficial in the transplant setting. Animal studies have demonstrated the utility of 1,25-(OH)2D3 in prolonging allograft survival. Therefore, we evaluated the effects of 1,25-(OH)2D3 (oral calcitriol) in human renal transplant recipients. Methods: A case-control study was undertaken assessing the effects of calcitriol on transplant function. The effect of calcitriol on renal function was analyzed using general linear mixed modeling of the change in slope of serum creatinine (Scr) prior to and following the start of calcitriol therapy. Results: There was a significant increase in baseline Scr (p < 0.001) prior to starting calcitriol. Following initiation of calcitriol, there was a deceleration in the rate of loss of graft function (p = 0.031 at day 300 of therapy). Graft survival was also prolonged in calcitriol-treated patients compared to a control population with evidence of chronic allograft nephropathy but no calcitriol therapy (p < 0.03). Overall, there were no adverse or harmful effects related to calcitriol therapy. 1,25-(OH)2D3 therapy was associated with (1) a deceleration in the rate of loss of renal function in transplant recipients with more than one year of allograft function, and (2) no significant change in allograft function early after transplantation. Conclusion: These data suggest that short- and long-term prospective trials evaluating 1,25-(OH)2D3 or 1,25-(OH)2D3 analogs in human kidney transplantation are warranted. Such trials may help us elucidate mechanism and duration of action, as well as safety issues related to these novel immunomodulatory agents.
HIPAA appears to inhibit medical record and database research. Ethical considerations in healthcare research are paramount, but current HIPAA implementation strategies increase workload for HSC and researchers, and increase the dropout rate for proposed studies when investigators are unable or unwilling to meet the regulatory requirements. It is unclear whether or to what degree the new requirements add to protection of privacy. Studies designed to investigate the costs and effects on quantity and/or quality of research should be prospectively implemented.
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