Outcomes of tacrolimus therapy in adults with refractory membranous nephrotic syndrome: a prospective, multicenter clinical trial.

The treatment of adult refractory idiopathic membranous nephropathy with steroid and other immunosuppressant-resistant nephrotic syndrome can be a significant challenge. The authors investigated the efficacy and safety of tacrolimus (TAC) as a promising regimen.
A prospective, multicenter trial was conducted in 9 nephrology centers from 2006 to 2008. Fourteen patients were enrolled. In conjunction with prednisone, TAC was started at 0.05 mg/kg/d, titrated to achieve a trough blood level of 5 to 10 ng/mL for the first 6 months, then reduced to 4 to 6 ng/mL for the subsequent 6 months. The primary endpoints included complete or partial remission. Secondary endpoints included relapse, change of clinical parameters and adverse events.
After 12 months, complete remission was achieved in 35.7% of patients and partial remission in 42.9%, yielding a response rate of 78.6%. Proteinuria, serum albumin, cholesterol, triglyceride and low-density lipoprotein were improved significantly (P < 0.001, P < 0.001, P = 0.002, P = 0.01, P = 0.004, respectively). Proteinuria and serum albumin were significantly improved (42.0% ± 13.2%, P = 0.02; 15.2% ± 4.5%, P = 0.01, respectively) even after the first month of treatment. One patient relapsed during the subsequent 6 months of follow-up. Adverse events included 2 cases of infection and 1 case each of hyperglycemia, hand tremor, sudden death (nondrug related) and diarrhea.
TAC plus prednisone may be an alternative therapeutic option for steroid and general immunosuppressant-resistant membranous nephrotic syndrome patients, with a favorable safety profile. However, given the limitation of a small number of patients in this trial, further study with a larger number and longer follow-up is needed.
AuthorsWei Chen, Qinghua Liu, Yunhua Liao, Zhenhua Yang, Jian Chen, Junzhou Fu, Jinli Zhang, Yaozhong Kong, Ping Fu, Tanqi Lou, Zhengrong Liu, Yulian Ji, Zhibin Li, Xueqing Yu
JournalThe American journal of the medical sciences (Am J Med Sci) Vol. 345 Issue 2 Pg. 81-7 (Feb 2013) ISSN: 1538-2990 [Electronic] United States
PMID22627258 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Immunosuppressive Agents
  • Prednisone
  • Tacrolimus
  • Adult
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents (administration & dosage)
  • Male
  • Middle Aged
  • Nephrotic Syndrome (blood, drug therapy, immunology)
  • Prednisone (administration & dosage)
  • Prospective Studies
  • Tacrolimus (administration & dosage)
  • Treatment Outcome

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