Tacrolimus Monotherapy after Intravenous Methylprednisolone in Adults with Minimal Change Nephrotic Syndrome

• DOI: 10.1681/asn.2016030342
• Publication Date: 2016-11-03T02:23:56Z
• Authors: Xiayu Li; Zhangsuo Liu; Li Wang; Rong Wang; Guohua Ding; Wei Shi; Ping Fu; Yani He; Genyang Cheng; Shukun Wu; Bing Chen; Juan Du; Zhiming Ye; Ye Tao; Bengang Huo; Heng Li; Jianghua Chen
• Keywords: Adult; Male; Nephrosis, Lipoid; Methylprednisolone; Tacrolimus; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Humans; Drug Therapy, Combination; Female; Prospective Studies; Infusions, Intravenous; Glucocorticoids

Glucocorticoid treatment is the first choice therapy for adults with minimal change nephrotic syndrome; however, this associates many adverse effects. Tacrolimus may be an alternative to conventional glucocorticoid therapy. To investigate 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 adult–onset syndrome ( n =119) receive or tacrolimus after intravenous methylprednisolone (0.8 mg/kg per day) 10 days. Patients received regimen monotherapy, starting 0.05 day (target trough whole–blood level of 4–8 ng/ml) 16–20 weeks and subsequently tapering over approximately 18 weeks. Remission occurred 51 53 (96.2%; all complete remission) glucocorticoid-treated 55 56 (98.3%; 52 three partial tacrolimus-treated P =0.61 remission; =0.68 remission). The groups had similar mean time remission =0.55). Relapse 49.0% 45.5% glucocorticoid- patients, respectively =0.71), relapse =0.86). Seven (13.7%) four (7.3%) suffered frequent =0.28); five two became drug dependent =0.26). Adverse events more frequently group (128 versus 81 group). were serious. Consequently, monotherapy short–term noninferior cohort.