a study looking at kidney function in kidney transplant recipients who are taking anti-rejection medication including tacrolimus and with or without sirolimus.

Conditions: Kidney Transplantation

Summary: the purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

this study will evaluate the potential to reduce nephrotoxic calcineurin inhibitors (cni) therapy by lowering tacrolimus exposure from advagraf® in combination with the non-nephrotoxic immunosuppressant sirolimus to avoid the risk of acute graft rejection, compared with an advagraf® and mycophenolate mofetil (mmf) immunosuppressive regimen.

Eligibility criteria:
inclusion criteria: * end stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months) * receiving a kidney transplant from a deceased or living (non human leukocyte antigen \[hla\] identical) donor with compatible abo blood type * female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment * female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. a highly effective method of birth control is defined as those which result in a low failure rate (cpmp/ ich/ 286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devises (iuds), sexual abstinence or vasectomized partner exclusion criteria: * receiving or having previously received an organ transplant other than a kidney * cold ischemia time of the donor kidney \> 30 hours * panel reactive antibody (pra) \>20% * receiving a graft from a non-heart-beating donor other than of maastricht category 3 (withdrawal of support awaiting cardiac arrest) * significant liver disease, defined as having continuously elevated sgpt/ alt and/ or sgot/ ast and/ or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis c or b positive donor * requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s) * requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy) * significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer * pregnant woman or breast-feeding mother * subject or donor known to be hiv positive * known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, mmf or any of the product excipients or iodine * evidence of malignant disease within the last 5 years, not including non-malignant skin cancers * currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment * unlikely to comply with the visits scheduled in the protocol

Keywords: kidney kidney failure, acute astagraf xl immunosuppression advagraf tacrolimus transplant