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.
Current therapy for inherited proteinuric kidney disease remains limited. Renin-angiotensin-aldosterone-system (RAAS) inhibitors such as Angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) help to control proteinuria and slow the progression of kidney function loss. However, a substantial proportion of patients progress to end-stage renal disease, which is partly associated with high residual proteinuria. Novel therapies to decrease proteinuria and limit CKD progression are needed. Traditional Chinese medicine (TCM) has been extensively used in China for thousands of years and favored in treatment of chronic disease for multi-factorial, multi-target action. The investigators' hypothesis is that this traditional Chinese medicine, targeted to podocyte injury and repair named Gu Shen Juan Yu Formula, can significantly reduce proteinuria and delay renal function loss in patients with proteinuric kidney disease. To test this hypothesis, the investigators plan to initiate a multicenter, open-label, two-arm, crossover, randomized clinical trial in 72 children with proteinuria kidney disease. The study population will consist of children with proteinuria who are on receiving routine therapy such as ACE inhibitor or angiotensin II receptor blocker treatment. In this study, participants were randomly assigned (1:1) to receive first either TCM+Routine Therapy or Routine Therapy for 12 weeks. A 2 weeks washout period was used before crossover. The primary objective was to measure the change of urine protein excretion and estimated glomerular filtration rate (eGFR) during the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
Patients receive a stable dose of ACEI/ARB drug as a routine therapy.
Anhui Provincial Children's Hospital
Hefei, Anhui, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, China
Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital
Zhengzhou, Henan, China
Percentage change in urinary protein-creatinine ratio (UPCR) from baseline to week 26
UPCR in first-morning spot urine samples are measured at baseline, week 12, week 14, and week 26. It is a repeated measurement.
Time frame: baseline, week 12, week 14, week 26
Changes in estimated glomerular filtration rate (eGFR) from baseline to week 26
eGFR will be evaluated using Schwartz formula (eGFR=k\*height(cm)/serum creatinine(umol/L)), k=36.5). Serum creatinine are measured at baseline, week 12, week 14, week 26. Serum creatinine is a repeated measurement.
Time frame: baseline, week 12, week 14, week 26
Percentage change in urinary albumin-creatinine ratio (UACR) from baseline to week 26
UACR in first-morning spot urine samples are measured at baseline, week 12, week 14, and week 26. UPCR is a repeated measurement.
Time frame: baseline, week 12, week 14, week 26
Percentage change in 24-hour protein from baseline to week 26
24-hour urine samples are measured at baseline, week 12, week 14, and week 26. 24-hour proteinuria is a repeated measurement.
Time frame: baseline, week 12, week 14, week 26
Changes in serum albumin from baseline to week 26
Serum albumin are measured at baseline, week 12, week 14, and week 26. Serum albumin is a repeated measurement.
Time frame: baseline, week 12, week 14, week 26
Changes of Traditional Chinese Medicine syndrome scores after treatment
A TCM syndrome scale points are used to evaluate the Traditional Chinese Medicine syndromes at baseline, and week 26. The minimum values is 0 and maximum values is 36. The higher scores mean a severe status.
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Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology.
Wuhan, Hubei, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Shandong Provincal Hospital
Shandong, Shandong, China
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Children's Hospital of Fudan University
Shanghai, China
Xuzhou Children's Hospital
Xuzhou, China
Time frame: Baseline, week 26
Changes in liver function parameters from baseline to week 26: Alanine Aminotransferase (ALT)
Blood samples are measured at baseline, week 12, week 14, week 26 to evaluate ALT
Time frame: baseline, week 12, week 14, week 26
Changes in liver function parameters from baseline to week 26: Aspartate Aminotransferase (AST)
Blood samples are measured at baseline, week 12, week 14, week 26 to evaluate AST
Time frame: baseline, week 12, week 14, week 26