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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004925
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary glomerulonephritis (CKD Stage 3)

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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 = -1.209 for women: serum creatinine 0.7 mg / dl = -1.209); 3.Blood pressure control = 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

Exclusion criteria: 1.Patients with severe primary diseases including heart, brain, liver and hematopoietic system need prompt treatment; 2.24-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.

Design outcomes

Primary

MeasureTime frame
Change in glomerular filtration rate;

Secondary

MeasureTime frame
Urinary 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;

Countries

China

Contacts

Public ContactTao Yanyan

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

taoyanyan1023@126.com+86 13761573407

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026