Kidney Transplantation
Conditions
Keywords
Kidney transplantation, immunosuppression, sirolimus, Thymoglobulin
Brief summary
A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.
Detailed description
Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Primary cadaver or non-HLA identical living donor kidney transplant. -
Exclusion criteria
HIV HCV Pregnancy Age \< 18 years Malignancy \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient and graft survival | — |
| Biopsy proven acute rejection | — |
| Serum creatinine | — |
Secondary
| Measure | Time frame |
|---|---|
| Hyperlipidemia | — |
| lymphoceles | — |
| post-transplant diabetes | — |
| wound infections | — |
Countries
United States