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Tacrolimus Monotherapy after Intravenous Methylprednisolone in Adults with
Minimal Change Nephrotic Syndrome
#MMPMID27807213
Li X
; Liu Z
; Wang L
; Wang R
; Ding G
; Shi W
; Fu P
; He Y
; Cheng G
; Wu S
; Chen B
; Du J
; Ye Z
; Tao Y
; Huo B
; Li H
; Chen J
J Am Soc Nephrol
2017[Apr]; 28
(4
): 1286-1295
PMID27807213
show ga
Glucocorticoid treatment is the first choice therapy for adults with minimal
change nephrotic syndrome; however, this therapy associates with many adverse
effects. Tacrolimus may be an alternative to conventional glucocorticoid therapy.
To investigate this possibility, we conducted a prospective, randomized,
controlled trial (WHO International Clinical Trials Registry Platform:
ChiCTR-TRC-11001454) in eight renal units across China. We randomized enrolled
patients with adult-onset minimal change nephrotic syndrome (n=119) to receive
glucocorticoid therapy or tacrolimus after intravenous methylprednisolone (0.8
mg/kg per day) for 10 days. Patients received a conventional glucocorticoid
regimen or tacrolimus monotherapy, starting with 0.05 mg/kg per day (target
trough whole-blood level of 4-8 ng/ml) for 16-20 weeks and subsequently tapering
over approximately 18 weeks. Remission occurred in 51 of 53 (96.2%; all complete
remission) glucocorticoid-treated patients and 55 of 56 (98.3%; 52 complete and
three partial remission) tacrolimus-treated patients (P=0.61 for remission;
P=0.68 for complete remission). The groups had similar mean time to remission
(P=0.55). Relapse occurred in 49.0% and 45.5% of the glucocorticoid- and
tacrolimus-treated patients, respectively (P=0.71), with similar time to relapse
(P=0.86). Seven (13.7%) glucocorticoid-treated and four (7.3%) tacrolimus-treated
patients suffered frequent relapse (P=0.28); five glucocorticoid-treated and two
tacrolimus-treated patients became drug dependent (P=0.26). Adverse events
occurred more frequently in the glucocorticoid group (128 versus 81 in the
tacrolimus group). Seven adverse events in the glucocorticoid group and two
adverse events in the tacrolimus group were serious. Consequently, tacrolimus
monotherapy after short-term intravenous methylprednisolone is noninferior to
conventional glucocorticoid treatment for adult-onset minimal change nephrotic
syndrome in this cohort.
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