Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open study

• Register: ChiCTR
• Last refreshed on: 21 May 2018
• Main ID: ChiCTR1800016140
• Date of registration: 2018-05-14
• Prospective Registration: Yes
• Primary sponsor: Sichuan Provincial People's Hospital
• Public title: Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open study
• Scientific title: A randomized controlled trial for the treatment of primary membranous nephropathy
• Date of first enrolment: 2018-07-01
• Target sample size: Tacrolimus group:45;Cyclophosphamide group:45;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=27170
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Li Wang
• Affiliation: Sichuan Provincial People's Hospital

• Name: Li Wang
• Affiliation: Sichuan Provincial People's Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1) signing the written informed consent;
2) patients aged between 18~65 years old, male or female;
3) clinical diagnosis of primary nephrotic syndrome (albuminuria >3.5 g/d, serum albumin <30 g/L);
4) diagnosed as idiopathic membranous nephropathy by renal biopsy;
5) the results of pregnancy test for women of childbearing age were negative and agreed to adopt contraceptive measures;
6) serum creatinine <133umol/L.
Exclusion criteria: 1) did not sign written informed consent or unable or unwilling to comply with the research plan approved by the researchers;
2) secondary membranous nephropathy (tumor, medicine, etc.);
3) have received hormone or other immunosuppressive drugs (cyclosporine and mycophenolate mofetil);
4) known to be allergic to tacrolimus, glucocorticoids, or any of the above drugs;
5) HBV serological index (HBsAg or / and HBeAg) positive, HCV positive or patients with abnormal liver function (2 times or more of ALT, AST or bilirubin above the upper limit of normal value, and continue to rise for 2 weeks);
6) the diagnosis was diabetes (defined as fasting blood glucose more than 7 mmol/L or diabetic symptoms + random blood sugar more than 11.1 mmol/L or 2 hours of glucose more than 11.1 mmol/L) or impaired glucose tolerance (2 hours of glucose 7.8 – 11 mmol/L);
7) there was a definite history of gastrointestinal ulcer and / or gastrointestinal bleeding within 6 months;
8) congenital or acquired immunodeficiency, or active tuberculosis and active CMV infection. Patients with severe infections need to use antibiotics intravenously;
9) patients with other serious physical or mental disorders;
10) congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases;
11) women who are pregnant, nursing or unwilling to take contraceptive measures;
12) patients who took part in other clinical trials in the first three months;
13) the researchers judged that the patient's condition was not suitable for the study.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

primary membranous nephropathy

Intervention(s)

Tacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks;

Primary Outcome(s)

Complete remission rate;Partial remission rate;Recurrence rate;

Source(s) of Monetary Support

self-financing

Ethics review

Status: Approved
Approval date: 16/03/2018
Contact:

Zhengping Yong

[phone]