Liver transplantation recipients with renal dysfunction may benefit from mycophenolate mofetil and reduction or discontinuation of nephrotoxic calcineurin inhibitors.
Dr David Reich and colleagues report the first randomized, multicenter pilot studies of this approach, 1 in cyclosporine and 1 for those on tacrolimus.
The investigative team included patients 3 to 27 months post-liver transplantation with greater than 20% reduced renal function since the operation.
The patients also had creatinine 1.8 to 4.0 mg/dL, creatinine clearance 20 to 60 mL/min, or both.
Patients were randomized to discontinuation in Group 1 or to a 50% reduction of nephrotoxic calcineurin inhibitors dose, with mycophenolate mofetil 1.5 g twice daily and prednisone in Group 2.
The team included endpoints that measured glomerular filtration rate 52 weeks after study entry and biopsy-proven rejection.
In the cyclosporine and tacrolimus trials, 15 and 12 patients, respectively, completed the 52-week follow-up.
|The mean glomerular filtration rate in the cyclosporine trial changed from 35 to 58 mL/min at week 52|
In the cyclosporine trial, the team found that the mean glomerular filtration rate at baseline and week 52 were 35 and 58 mL/min for Group 1.
The investigators noted that the mean glomerular filtration rate at baseline and week 52 for Group 2 were 46 and 64 mL/min.
In the tacrolimus trial, glomerular filtration rates were 55 and 56 mL/min for Group 1 vs 46, and 60 mL/min for Group 2, at baseline and week 52, respectively.
The investigators noted that mild or moderate rejection occurred in 38% and 9% of patients in Groups 1 and 2 of the cyclosporine trial.
Mild or moderate rejection in the tacrolimus trial occurred in 14% of each group of the patients.
Dr Reich's team concludes, “These pilot studies show that in liver transplantation recipients with renal dysfunction, mycophenolate mofetil allows nephrotoxic calcineurin inhibitors dose reduction or discontinuation.”
“It also improves or stabilizes glomerular filtration rate in most patients.”