Conditions: Kidney Transplantation
Keywords: Kidney Transplantation Immunosuppressive Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief summary:
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.

Detailed description:
One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al concluded that cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe acute rejection and better lipid profiles than cyclosporine-treated patients.

Cardiovascular disease is the primary cause of premature death in renal and other transplant recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk factors such as hypertension, hyperlipidemia, obesity and diabetes.

This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Arms:
arm 1: Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL. arm 2: Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL. arm 3: Convert to TAC at target trough levels of 6.0-8.9 ng/mL.

Interventions: intervention 1: cyclosporine intervention 2: Prograf (Tacrolimus)
Intervention descriptions: intervention 1: Maintain on cyclosporine at target trough level of 50-250 ng/mL. intervention 2: Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).

Protocol document: