NCT03549663Unknown不适用
Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Complete remission rate of 24-hour urine protein
研究概览
简要总结
The trial is a random, open, control and monocentric trial. Mainly to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN). Assuming that the urine protein remission rate of 48-week TAC for monotherapy of IMN is not lower than that in treatment group of TAC combined with glucocorticoid, attempt on de-hormonal therapy in the future IMN therapy can be attempted on the basis of the trial results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 80 years;
- •Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
- •Those who meet any of the following high-risk IMN standards:
- •Urinary protein>8g/24h
- •Serum albumin<25g/l
- •Serum PLA2R levels are 5 times higher than normal
- •eGFR decline rate after confirmed IMN within 6-12 months is ≥30%
- •Patients with serious complications: pulmonary embolism, lower extremity static Vein thrombosis/embolism, acute renal injury, etc.
- •Those without reaching the above high-risk IMN standard, but their course of disease is >6 months without spontaneous remission,and still present nephrotic syndrome;
- •Patients who have signed the informed consent forms.
排除标准
- •Those whose kidney pathological manifestation of interstitial fibrosis is >30%;
- •Those who are positive in active Hepatitis B (including HBsAg, HBeAg and HBcAb or HBsAg, HBeAb and HBC) or serological indexes (HBsAg or/and HBeAg or/and HBcAb) or infected with Hepatitis C, tuberculosis, cytomegalovirus, severe fungal or HIV infection;
- •Those who suffer from untreated active digestive tract ulcer within 3 months before random grouping;
- •Those who suffer from uncured malignant tumor for less than 5 years
- •Those who received glucocorticoid (prednisone or prednisolone), mycophenolatemofetil, tacrolimus, cyclosporine A and other drugs for treatment within 3 months before screen with a course of treatment exceeding 4 weeks or those who received cyclophosphamide (accumulated dose>1.0g);
- •Those whose ALT, AST or total bilirubin content goes beyond 1.5 times above normal upper limit;
- •Those who suffer from combined critical complications such as serious infection or other severe organ disease or dysfunction;
- •Pregnant or lactating women;
- •Those who are known to be allergic to drugs under trial or relevant products;
- •Those who participated in other clinical trials within 3 months before inclusion;
- •The patients who cannot comply with the research proposal as determined by the supervising physician.
- •Exit criteria
- •Those with incomplete or partial relieved proteinuria for 6 months after treatment;
- •Patients or their legal guardians voluntarily requests to withdraw;
- •Those against the inclusion criteria and exclusion criteria;
- •Those who need to take medications prohibited by the trail;
- •Those with poor compliance or stopping the drug for over 2 weeks;
- •Those with uncontrollable infection;
- •Those whit elevated blood glucose during the treatment, which is still difficult to control after routine treatment by endocrinologists;
- •In the TAC group, the eGFR decreased by >30%, the TAC dose was halved. And the drug concentration and renal function were reviewed after 2 weeks. If the eGFR decreased by <30%, it will continue to be used; if the eGFR still decreased by >30%, the TAC dose continues to halve, or give a minimum dose of 0.5mg / d. And the drug concentration and renal function were reviewed after 2 weeks. If the eGFR decreased by <30%, TAC will continue to be used, otherwise stop the drug;
- •Those whose ALT, AST or bilirubin rises to more than 2 times the upper limit of normal value after treatment, and continues to increase for 2 weeks; those whose ALT, AST or bilirubin rises to more than 2 times the upper limit of normal value after 2 weeks of treatment with liver protection, the drug will be discontinued. If it cannot be recovered after 2 weeks, the patient will withdraw;
- •Those with other unexplained severe comorbidities;
- •Those with pregnancy during treatment;
- •For security reasons, the research sponsor proposed to stop the study;
研究组 & 干预措施
Tacrolimus monotherapy
Experimental
干预措施: Tacrolimus (Drug)
Tacrolimus combined with hormone therapy
Active Comparator
干预措施: Tacrolimus (Drug)
Tacrolimus combined with hormone therapy
Active Comparator
干预措施: Prednisone (Drug)
结局指标
主要结局
Complete remission rate of 24-hour urine protein
时间窗: At week 48
The proportion of patients with complete remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of complete remission: post-therapy urine protein level is \<0.3g/24h.
次要结局
- Partial remission remission rate of 24-hour urine protein(At week 48)
- Number of patients with adverse events(up to 48 weeks)
- PLA2R antibody negative conversion rate(At week 48)
研究者
研究点 (1)
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