tacrolimus monotherapy for idiopathic membranous nephropathy

Conditions: Tacrolimus; Idiopathic Membranous Nephropathy; Clinical Trial

Summary: 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).


Eligibility criteria:
inclusion criteria: 1. age: 18 - 80 years; 2. those whose clinical manifestation and renal biopsy pathologic diagnosis are imn (stages i-iv) with secondary membranous nephropathy excluded; 3. 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. 4. 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; 5. patients who have signed the informed consent forms. exclusion criteria: 1. those whose kidney pathological manifestation of interstitial fibrosis is \>30%; 2. 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; 3. those who suffer from untreated active digestive tract ulcer within 3 months before random grouping; 4. those who suffer from uncured malignant tumor less than 5 years; 5. 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; 6. those whose alt, ast or total bilirubin content goes beyond 1.5 times above normal upper limit; 7. those who suffer from combined critical complications such as serious infection or other severe organ disease or dysfunction; 8. pregnant or lactating women; 9. those who are known to be allergic to drugs under trial or relevant products; 10. those who participated in other clinical trials within 3 months before inclusion; 11. the patients who cannot comply with the research proposal as determined by the supervising physician. exit criteria 1. those with incomplete or partial relieved proteinuria for 6 months after treatment; 2. patients or their legal guardians voluntarily requests to withdraw; 3. those against the inclusion criteria and exclusion criteria; 4. those who need to take medications prohibited by the trail; 5. those with poor compliance or stopping the drug for over 2 weeks; 6. those with uncontrollable infection; 7. those whit elevated blood glucose during the treatment, which is still difficult to control after routine treatment by endocrinologists; 8. 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%, 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; 9. 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; 10. those with other unexplained severe comorbidities; 11. those with pregnancy during treatment; 12. for security reasons, the research sponsor proposed to stop the study;