Fuzheng huayu tablets against renal fibrosis in primary glomerulonephritis (CKD stage 3): a randomized, double-blind, placebo-controlled, multicenter clinical trial

Phase 1

Recruiting

• Conditions: Primary glomerulonephritis (CKD Stage 3)

• Registration Number: ITMCTR2100004925
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in glomerular filtration rate;

Secondary Outcome Measures

Name	Time	Method
rinary transforming growth factor -ß1 is a specific indicator of renal fibrosis;Cystatin C;Urea nitrogen;Change value of ß2 microglobulin;Change in glomerular filtration rate;Change value of urine protein quantification at 24h;Blood lipid changes after treatment;Change value of serum creatinine;Traditional Chinese Medicine symtom score;Hemoglobin;Blood uric acid;