Tacrolimus combined with corticosteroids in treatment of nephrotic idiopathic membranous nephropathy: a multicenter randomized controlled trial.
BACKGROUND
Idiopathic membranous nephropathy (IMN), a common cause of nephrotic syndrome in adults, is usually treated with corticosteroids in combination with cyclophosphamide or cyclosporine. A recent placebo-controlled study suggested that tacrolimus monotherapy was effective in IMN. However, the effectiveness of tacrolimus versus classic regimen and its potential nephrotoxicity remain inconclusive. This study evaluated the efficacy and safety of tacrolimus plus prednisone in patients with nephrotic IMN.


METHODS
Seventy-three patients with nephrotic IMN were recruited in this multicenter randomized controlled trial, 39 receiving tacrolimus and prednisone, while 34 receiving cyclophosphamide and prednisone. Tacrolimus was given at 0.1 mg/kg/d initially and adjusted to a blood trough level at 5 to 10 ng/mL for 6 months and then reduced to 2 to 5 ng/mL in the subsequent 3 months.


RESULTS
Intention-to-treat analysis suggested that the remission rate at the end of the sixth month was significantly higher in tacrolimus group than that in cyclophosphamide group (85% versus 65%, P < 0.05). The decrease of proteinuria was significantly greater in tacrolimus group. At the end of the 12th month, the remission rates were comparable between these 2 groups. Patients treated with tacrolimus were more likely to develop glucose intolerance (or diabetes mellitus), infection, and hypertension. No obvious nephrotoxicity of calcineurin inhibitor was found in repeat renal biopsy.


CONCLUSIONS
Tacrolimus plus corticosteroids is an alternative therapeutic regimen for nephrotic IMN. The short-term efficacy might be better than cyclophosphamide plus prednisone.
Chen
Min
M
Department of Nephrology, Peking University First Hospital, Beijing, China.
Li
Hang
H
Li
Xia-Yu
XY
Lu
Fu-Ming
FM
Ni
Zhao-Hui
ZH
Xu
Fei-Fei
FF
Li
Xue-Wang
XW
Chen
Jiang-Hua
JH
Wang
Hai-Yan
HY
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015433:Glomerulonephritis, Membranous / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009404:Nephrotic Syndrome / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D016559:Tacrolimus