NCT03864250Unknown不适用
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2018年11月26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
- 124
- 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
This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN).
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 infection, syphilis 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 less than 5 years;
- •Those who received glucocorticoids (prednisone or prednisolone), mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, tripterygium and other immunosuppressive agents for treatment within 3 months before screening;
- •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)
- PLA2R antibody negative conversion rate(At week 48)
- Number of patients with adverse events(Up to 48 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic SyndromeMinimal Change DiseaseNCT01084980Seoul National University Hospital20
已完成
2 期
Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromeIdiopathic Membranous NephropathyNephrotic SyndromeNCT00362531Peking University
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy PatientsIgA NephropathyNCT01224028Astellas Pharma Inc40
已完成
1 期
Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy SkinHealthyNCT03673527LEO Pharma24
已完成
4 期
Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisLupus Erythematosus, SystemicLupus NephritisNCT00125307Chinese University of Hong Kong20