Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
BMC Nephrol. 2019 Sep 6;20(1):352. doi: 10.1186/s12882-019-1539-z.
Tacrolimus (TAC) is effective in treating membranous nephropathy (MN); however relapses are frequent after treatment cessation. We conducted a randomised controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC would reduce relapse rate.
Forty patients with biopsy proven idiopathic MN and nephrotic syndrome were randomly assigned to receive either TAC monotherapy (n = 20) or TAC combined with MMF (n = 20) for 12 months. When patients had been in remission for 1 year on treatment the MMF was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also received supportive treatment with angiotensin blockade, statins, diuretics and anticoagulation as needed. Primary endpoint was relapse rate following treatment withdrawal. Secondary outcomes were remission rate, time to remission and change in renal function.
16/20 (80%) of patients in the TAC group achieved remission compared to 19/20 (95%) in the TAC/MMF group (p = 0.34). The median time to remission in the TAC group was 54 weeks compared to 40 weeks in the TAC/MMF group (p = 0.46). There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7). The addition of MMF to TAC did not adversely affect the safety of the treatment.
Addition of MMF to TAC does not alter the relapse rate of nephrotic syndrome in patients with MN.
This trial is registered with EudraCTN2008-001009-41 . Trial registration date 2008-10-08.
他克莫司（TAC）在治疗膜性肾病（MN）方面有效；然而，治疗停止后复发频繁。我们进行了一项随机对照试验，以检验霉酚酸酯（MMF）联合 TAC 是否会降低复发率。
40 名经活检证实的特发性 MN 伴肾病综合征患者被随机分为 TAC 单药治疗组（n=20）或 TAC 联合 MMF 治疗组（n=20），治疗 12 个月。当患者在治疗 1 年后达到缓解，MMF 在两组中均停用，TAC 在 6 个月内逐渐停用。两组患者均接受血管紧张素阻断、他汀类药物、利尿剂和抗凝治疗。主要终点是治疗停药后的复发率。次要结局是缓解率、缓解时间和肾功能变化。
TAC 组 20 例患者中有 16 例（80%）达到缓解，TAC/MMF 组 20 例患者中有 19 例（95%）达到缓解（p=0.34）。TAC 组缓解中位时间为 54 周，TAC/MMF 组为 40 周（p=0.46）。两组复发率无差异：TAC 组 16 例中有 8 例（50%）复发，TAC/MMF 组 19 例中有 8 例（42%）复发（p=0.7）。TAC 中添加 MMF 并未影响治疗的安全性。
TAC 中添加 MMF 不会改变 MN 患者肾病综合征的复发率。
本试验在 EudraCTN2008-001009-41 注册。试验注册日期 2008-10-08。
