Mild to moderate IgA nephropathy
Conditions
Interventions
Control Group:Oral telmisartan 40 mg per dose, once daily.
Experimental Group:In addition to the control group, oral administration of Zhibai Dihuang Pills was given at a dose of 30 pills (6 grams) twice daily.
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed by kidney biopsy as primary IgA nephropathy, with Oxford MEST-C classification completed by a pathologist. To enrich the population with active lesions at risk of progression, patients must meet at least one of the following seven criteria: 1) Mesangial cell proliferation =50% (M0), 2) Endothelial cell proliferation in capillaries (E1), 3) Segmental glomerulosclerosis (S1), 4) Tubular atrophy/interstitial fibrosis =25% (T0), 5) Tubular atrophy/interstitial fibrosis 26%~50% (T1), 6) Crescent formation <25% (C1), 7) Crescent formation =25% (C2); (2) Meets the diagnostic criteria of Traditional Chinese Medicine for liver and kidney yin deficiency and/or hyperactivity of fire in the chronic persistent phase of IgA nephropathy; (3) 24-hour urine protein quantification is =0.5g and <2.5g, with chronic kidney disease (CKD) staging at 1~3a; (4) Aged 18-80 years (inclusive), gender; (5) Good compliance, willing to cooperate with this study, able to accept related treatments and various physical and chemical examinations; (6) Patients are informed, agree to participate in this clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presents with severe proteinuria (24-hour urine protein quantification =2.5g); (2) Patients with advanced, irreversible chronic kidney damage as determined by kidney biopsy, defined as tubular atrophy/interstitial fibrosis >50% (T2) or global glomerulosclerosis >50%, mesangial cell proliferation score >0.5 (M1), or tubular atrophy/interstitial fibrosis (T) >50% (T2); (3) Patients with unilateral or bilateral renal artery stenosis; (4) Patients with systemic lupus erythematosus, purpura nephritis, hepatitis B, or diabetic nephropathy; (5) Patients with deficiencies in other immune systems, such as hematological, respiratory, urinary, digestive, or neurological systems; (6) Patients with severe comorbidities, including severe kidney failure (CKD stages 3b-5), severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels >2 times the upper limit of normal, or investigator), uncontrolled cardiovascular diseases, or other severe systemic diseases; (7) Females with recent plans for pregnancy, currently pregnant, or breastfeeding; (8) Patients with allergies to the investigational drug or its related ingredients; (9) Patients who have participated in other drug clinical trials within the past three months or are currently participating in other drug clinical trials; (10) Other situations deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour proteinuria quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| estimated Glomerular filtration rate(eGFR) and Serum Creatinine(Scr);Blood Urea Nitrogen (BUN), Uric Acid (UA), Albumin (ALB), Total Cholesterol (TCH), Triglycerides (TG);Urinalysis;Traditional Chinese Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactLiu Bao Li
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed