Effects of Traditional Chinese Medicine (GSJYF) in Children With Inherited Proteinuric Kidney Disease

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759754
• Other study ID #: TCMinpKD
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: Hong Xu, PhD
• Phone: +86-02164932825
• Email: hxu[@]shmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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, parallel-design, randomized clinical trial in 144 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 TCM+ Routine Therapy or Routine Therapy for 12 weeks. The primary objective was to measure the change of urine protein excretion and estimated glomerular filtration rate (eGFR) during the treatment period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuria

Intervention

Drug:
• 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.
• Routine Therapy
Patients receive a stable dose of ACEI/ARB drug as a routine therapy.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangzhou
China	The Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Children's Hospital	Hefei	Anhui
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Shandong Provincal Hospital	Shandong	Shandong
China	Children's Hospital of Fudan University	Shanghai
China	Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology.	Wuhan	Hubei
China	Xuzhou Children's Hospital	Xuzhou
China	Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital	Zhengzhou	Henan

Sponsors (9)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Anhui Provincial Children's Hospital, Children's Hospital of Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Shandong Provincial Hospital, The Children's Hospital of Zhejiang University School of Medicine, Wuhan Union Hospital, China, Xuzhou Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects reporting adverse events (AEs)during the treatment period	Number of subjects with AEs as a measure of safety	baseline, week 4, week 8, week 12
Primary	Percentage change in urinary protein-creatinine ratio (UPCR) from baseline to week 12	UPCR in first-morning spot urine samples are measured at baseline, week 4, week 8, and week 12. It is a repeated measurement.	baseline, week 4, week 8, week 12
Primary	Changes in estimated glomerular filtration rate (eGFR) from baseline to week 12	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 4, week 8, week12. Serum creatinine is a repeated measurement.	baseline, week 4, week 8, week 12
Primary	Percentage change in urinary albumin-creatinine ratio (UACR) from baseline to week 12	UACR in first-morning spot urine samples are measured at baseline, week 4, week 8, and week 12. UPCR is a repeated measurement.	baseline, week 4, week 8, week 12
Primary	Percentage change in 24-hour protein from baseline to week 12	24-hour urine samples are measured at baseline, week 4, week 8, and week 12. 24-hour proteinuria is a repeated measurement.	baseline, week 4, week 8, week 12
Secondary	Changes in serum albumin from baseline to week 12	Serum albumin are measured at baseline, week 4, week 8, and week 12. Serum albumin is a repeated measurement.	baseline, week 4, week 8, week 12
Secondary	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 12. The minimum values is 0 and maximum values is 36. The higher scores mean a severe status.	Baseline, week 12
Secondary	Changes in liver function parameters from baseline to week 12: Alanine Aminotransferase (ALT)	Blood samples are measured at baseline, week 4, week 8, week 12 to evaluate ALT	baseline, week 4, week 8, week 12
Secondary	Changes in liver function parameters from baseline to week 12: Aspartate Aminotransferase (AST)	Blood samples are measured at baseline, week 4, week 8, week 12 to evaluate AST	baseline, week 4, week 8, week 12