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A prospective, single center, randomized, double-blind, controlled trial comparing the efficacy and safety of total saponins extracted from leaves of rehmannia(TSELR) in the treatment of IgA nephropathy in children

A prospective, single center, randomized, double-blind, controlled trial comparing the efficacy and safety of total saponins extracted from leaves of rehmannia(TSELR) in the treatment of IgA nephropathy in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083736
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

IgA nephropathy

Interventions

Test group:If the 24-hour urine protein quantification does not exceed 50mg/(kg/d) If the renal pathology only shows moderate or below mesangial hyperplasia, and there are no relevant contraindication
Primary IgA nephropathy with crescent formation was treated with high-dose methylprednisolone pulse therapy once (15-30mg/kg per day, for 3 days, with a maximum daily dose not exceeding 0.5g) in addit

Sponsors

the First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as primary IgA nephropathy through renal biopsy. 2. Age greater than 3 years old, less than 18 years old, and weight greater than 10kg. 3. Voluntarily participate in this study and sign an informed consent form. Children under the age of 18 shall be signed by their guardians. 4. eGFR = 90ml/min/1.73m2.

Exclusion criteria

Exclusion criteria: 1. Rapidly progressive glomerulonephritis or renal pathological diagnosis of crescentic glomerulonephritis; 2. People infected with HIV, hepatitis B, hepatitis C and tuberculosis; Individuals with a history of organ transplantation or hematopoietic stem cell transplantation; 3. Individuals with epilepsy, hearing and visual impairments; 4. Patients who refuse to cooperate with clinical research; 5. Other reasons leading the researcher to believe that it is not suitable to participate in this study; 6. Combined liver dysfunction: aspartate aminotransferase (AST) = 2 times the upper limit of normal or alanine aminotransferase (ALT) = 2 times the upper limit of normal; 7. Patients who are allergic to the ingredients or any excipients in this product.

Design outcomes

Primary

MeasureTime frame
Urinary protein quantification;Frequency of 50% reduction in urine protein;Rate of change in urine protein;

Secondary

MeasureTime frame
eGFR;Disappearance of bloody urine;

Countries

China

Contacts

Public ContactZhang jianjiang

the First Affiliated Hospital of Zhengzhou University

zhangjianjiang10@163.com+86 159 3626 9856

Outcome results

None listed

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