Preclinical study on the expanded indications of Fuzheng Huayu Tablets against renal fibrosis

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1.Aged 18 to 70 years, gender: male or female;
•2.In line with the Western medical diagnostic criteria for chronic kidney disease,patients with CKD grade 3(eGFR>30-59 ml / min / 1.73m^2) according to the K / DOQI recommended grading criteria for renal impairment and who had renal biopsy pathological data of glomerulonephritis (CKD grade 3).The EPI formula as follows: eGFR=ax(Scr/b)^Cx0.993^Age(a values were taken separately according to gender as follows, male = 141 female = 144; The b values are taken as follows depending on gender, male = 0.9 female = 0.7; The c value takes the following values based on age and size of serum creatinine, respectively, for men: serum creatinine <= 0.7 mg / dl = -0.411 serum creatinine > 0.7 mg / dl = -1.209 for women: serum creatinine <= 0.7 mg / dl = -0.329 serum creatinine > 0.7 mg / dl = -1.209);
•3.Blood pressure control <= 140 / 90 mmHg with SBP >= 100 mmHg and DBP >= 60 mmHg;
•4.Severe infections, water, electrolyte and acid-base balance disorders are effectively controlled, and serum potassium is within the normal range;
•5.Testing after 2 weeks of the lead-in period was eligible for patients with GFR: 30-59 ml / min / 1.73m^2 and BP <= 140 / 90 mmHg(patients are taking calcium antagonists, diuretics, and sympathetic nerve suppression do not need to enter the lead-in period);
•6.Volunteered to participate in the clinical study and agreed to sign an informed consent form.

•1.Patients with severe primary diseases including heart, brain, liver and hematopoietic system need prompt treatment;
•2.24-hour urine protein quantification <0.3g; 24-hour urine protein quantification>2.0 g;
•3.Hb <=100g/L;
•4.Patients have had hemodialysis or peritoneal dialysis in the past;
•5.Secondary renal diseases such as diabetic nephropathy or multiple myeloma should be excluded;
•6.Patients were participating in other clinical trials of drugs or had participated in other clinical trials within 3 months or had used western glucocorticoids, immunosuppressive agents, Tripterygium wilfordii preparations;
•7.Patients had taken other traditional Chinese medicines for nearly 2 weeks, which might affect the judgment of efficacy, can only be selected after two weeks of elution;
•8.If the patients have used angiotensin-converting enzyme inhibitors, or angiotensin receptor antagonists, they need to wash out 2 weeks before for being selected;
•9.Pregnant or lactating women;
•10.Allergic to drugs and their ingredients involved in this study;
•11.Patients with a previous history of hypotension;
•12.Patients with bilateral renal artery stenosis;
•13.Suspected or true history of alcohol or drug abuse;
•14.Patients after kidney transplantation, tumor or mental illness;
•15.The investigator believes that it is not suitable for participating in clinical trials.

发起方

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine