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Mean GFR at baseline in both treatment groups was 66.5 mL/min, indicating the study population had moderate renal insufficiency prior to study entry. However, the study did not meet its predefined primary efficacy end point of difference in baseline-adjusted Cockcroft�CGault GFR. In the absence of significant deterioration in the CNI-continuation patients, no ��benefit�� (i.e. absence of nephrotoxicity) could be demonstrated in the SRL-conversion group. Of note, a retrospective analysis of measured GFRs conducted to predict renal failure after LT showed a slow but steady decline in GFR, and the lower the initial post-transplant GFR, the sooner renal failure http://www.selleckchem.com/products/Maraviroc.html developed (21). Although based on a small number of patients, those with GFR http://www.selleckchem.com/products/pirfenidone.html reduction in renal function, as mean baseline GFR was 66 mL/min. While 12 months may have been insufficient to detect significant deterioration in the CNI-continuation group, continued follow-up beyond 12 months, albeit with diminishing numbers of patients remaining on assigned treatment, revealed little if any change over time. It is also important to note the prolonged time from transplantation to enrollment in this study. While inclusion criteria allowed for patients to enroll as early as 6 months posttransplantation, mean time from transplantation to randomization was 4.0 and 3.8 years (median 3.1 and 3.4) for the SRL-conversion and CNI-continuation groups, respectively. As a result, a substantial proportion of patients had extended CNI exposure and may have incurred irreversible nephrotoxic effects prior to switching to SRL. For the primary safety end point, no significant between-group difference was noted in graft survival rates. The majority of graft loss events (85%) in the SRL-conversion group occurred within 20 months; in the CNI-continuation group, half occurred after 20 months. With the exception of one retransplantation in the CNI-continuation group, all graft loss events were deaths (although no deaths were due to graft loss). Similarly, patient survival http://www.selleck.cn/products/Paclitaxel(Taxol).html rates were not significantly different between groups. Again, the majority of deaths in the SRL-conversion group occurred within 20 months. The numerically lower patient survival rate with SRL treatment was partly attributable to the deaths of four patients who, in violation of the protocol, had either clinical documentation of preexisting malignancy at enrollment, or in whom a malignancy was strongly suspected to have existed pre-enrollment, based on its early presentation after randomization.