Clinical trial
Treatment Effects of Traditional Chinese Medicine (Gu Shen Juan Yu Formula) in Children With Inherited Proteinuric Kidney Disease：a Multicenter, Open-label, Two-arm, Parallel-design, Randomized Clinical Trial
Name
TCMinpKD
Description
The purpose of this study is to determine whether traditional Chinese medicine, Gu Shen Juan Yu Formula, as complementary treatment is safe and effective in the treatment of Inherited Proteinuric Kidney Disease.
Trial arms
Trial start
2023-09-17
Estimated PCD
2024-07-01
Trial end
2024-10-01
Status
Recruiting
Treatment
TCM+ Routine Therapy
TCM：The Gu Shen Juan Yu Formula contains 11 herbs and it is available in liquid form for patients. Patients will receive Gu Shen Juan Yu Formula, 3g or 6g or 12g each time based on weight (3g for W≤20kg, 6g for 20-30kg, or 12g for W\>30kg), 2 times a day for 12 weeks, orally.
Routine therapy: Patients receiving a stable dose of ACEI/ARB will be continued.
Arms:
Traditional Chinese Medicine treatment group
Other names:
Gushen Juanyu Formula+ACEI/ARB
Routine Therapy
Patients receive a stable dose of ACEI/ARB drug as a routine therapy.
Arms:
Control group
Other names:
ACEI/ARB
Size
144
Primary endpoint
Percentage change in urinary protein-creatinine ratio (UPCR) from baseline to week 12
baseline, week 4, week 8, week 12
Changes in estimated glomerular filtration rate (eGFR) from baseline to week 12
baseline, week 4, week 8, week 12
Percentage change in urinary albumin-creatinine ratio (UACR) from baseline to week 12
baseline, week 4, week 8, week 12
Percentage change in 24-hour protein from baseline to week 12
baseline, week 4, week 8, week 12
Eligibility criteria
Inclusion Criteria:
* Aged 3-18 years；
* Proteinuria associated with hereditary nephropathy, which was confirmed by mutations in podocyte genes or syndromal genes (including collagens);
* Urine protein more than 500 mg/24 hours and/or UPCR (in first-morning void) more than 0.5 mg/mg at time of baseline despite ACEI or ARB treatment for at least 3 months;
* Estimated GFR ≥ 45 ml/min/1.73m2 (estimated with Schwartz formula);
* Without any immunosuppressive medications such as corticosteroids, calcineurin inhibitors, etc；
* On a stable dose of ACEI or ARB for at least 4 weeks；
* Willingness to give written consent and comply with the study protocol.
Exclusion Criteria:
* Diagnosed with Nephronophthisis, Polycystic kidney disease etc;
* With abnormal liver function, ALT or AST \>3.0 x upper limit of normal (ULN) at enrollment;
* Receiving immunosuppressive therapy (including corticosteroids, and other immune suppressive medicine) within three months prior to enrollment;
* Receiving other traditional Chinese medicine and/or its analogue which can reduce proteinuria within the past 2 weeks. Patients who are taking other TCM treatment could be enrolled after 2 weeks of wash out period;
* Has undergone major organ transplantation (e.g. heart, kidney, liver);
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, or metabolism including, but not limited to any of the following: active inflammatory bowel disease, received major gastrointestinal tract surgery;
* History of noncompliance to medical regimens or inability to comply with the study and follow-up procedures.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}
Updated at
2023-12-29
1 organization
2 products
3 indications
Organization
Children's Hospital of Fudan UniversityProduct
TCM Routine TherapyIndication
ProteinuriaIndication
Kidney DiseasesIndication
NephropathyProduct
Routine Therapy