Renal transplantationComplication: RenalConversion to Low-Dose Tacrolimus or Rapamycin 3 Months After Kidney Transplantation: A Prospective, Protocol Biopsy-Guided Study
Section snippets
Patients
This randomized prospective clinical trial was conducted at Buffalo General Hospital, Kaleida Health Care System, with informed consent and approval from the Institutional Review Board of SUNY, University at Buffalo. Adult patients who received their first kidney transplant were eligible to participate. Exclusion criteria included a class I panel-reactive antibody > 30%, simultaneous transplant of a second solid organ, history of malignancy, active pregnancy, total cholesterol > 300 mg/dL,
Results
A total of 58 patients were enrolled in the study. Six patients were removed from the study after the 3-month protocol biopsy because of subclinical inflammation; five had borderline changes and one had grade 1A rejection. Therefore, 52 patients were randomized at 3 months to either the LoTAC or SRL arm. The demographics for the two groups of randomized patients are shown in Table 1. The two groups were well matched except for a greater percentage of expanded criteria donor (ECD) kidneys
Discussion
Prolonging renal allograft survival remains one of the most important challenges in kidney transplantation. Indeed, long-term kidney transplant survival rates for both living and deceased donor transplants have not kept pace with the striking improvements achieved in short-term outcomes.5 A major cause of long-term allograft injury, fibrosis and functional decline, is CNI toxicity.6 This study examines the effect of reducing TAC levels or conversion to SRL at 3 months on renal allograft
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Cited by (16)
Calcineurin Inhibitor Minimization, Conversion, Withdrawal, and Avoidance Strategies in Renal Transplantation: A Systematic Review and Meta-Analysis
2016, American Journal of TransplantationMolecular mechanisms underlying the effects of cyclosporin A and sirolimus on glucose and lipid metabolism in liver, skeletal muscle and adipose tissue in an in vivo rat model
2014, Biochemical PharmacologyCitation Excerpt :CsA (Sandimmune Neoral®) was provided by Novartis Pharma (Lisbon, Portugal), while SRL (Rapamune) by Wyeth Europe Ltd (Berkshire, UK). The true blood concentration of CsA (367.0 ± 45.5 ng/ml) and SRL (7.8 ± 1.9 ng/ml) treatments were within the range of those achieved in humans under the same immunosuppressive regimens, while the recommended therapeutic windows are 200–400 ng/ml for CsA and 6–10 ng/ml for SRL [17]. A glucose tolerance test (GTT) was performed in fasted rats, 3 days before sacrifice.
Comparison of cyclosporine and sirolimus effects on serum creatinine level over five years after kidney transplantation
2013, Transplantation ProceedingsWound complications frequency in heart transplant recipients on mammalian target of rapamycin inhibitors: A meta-analysis
2023, International Wound JournalCampath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) – results of a randomized controlled clinical trial
2018, American Journal of Transplantation
This work was supported by an investigator-initiated research grant, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.