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

NCT05759754 | Completed

• 1 other identifier: TCMinpKD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Proteinuria; Kidney Diseases; Hereditary Nephropathy

Keywords

Traditional Chinese Medicine; anti-proteinuric

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  baseline, week 12, week 14, week 26

Secondary Outcomes (4)

• Changes in serum albumin from baseline to week 26

  baseline, week 12, week 14, week 26

• Changes of Traditional Chinese Medicine syndrome scores after treatment

  Baseline, week 26

• Changes in liver function parameters from baseline to week 26: Alanine Aminotransferase (ALT)

  baseline, week 12, week 14, week 26

• Changes in liver function parameters from baseline to week 26: Aspartate Aminotransferase (AST)

  baseline, week 12, week 14, week 26

Other Outcomes (1)

• Number of subjects reporting adverse events （AEs）during the treatment period

  baseline to week 26

Study Arms (2)

Group A

EXPERIMENTAL

TCM+Routine therapy are used first for 12 weeks, followed by 2 weeks wash-out period, then Routine therapy for 12 weeks. TCM as 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. The GSJYF samples were made and packed by Shanghai Fangxin Pharmaceutical Technology Co., LTD. with lot number of 20230830. Routine therapy: with stable dose of ACE inhibitors/ angiotensin II receptor blocker.

Drug: TCM+ Routine Therapy; Drug: Routine Therapy

Group B

EXPERIMENTAL

Routine therapy are used first for 12 weeks, followed by 2 weeks wash-out period, then TCM+Routine therapy for 12 weeks. TCM as 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. The GSJYF samples were made and packed by Shanghai Fangxin Pharmaceutical Technology Co., LTD. with lot number of 20230830. Routine therapy: with stable dose of ACE inhibitors/ angiotensin II receptor blocker.

Drug: TCM+ Routine Therapy; Drug: Routine Therapy

Interventions

TCM+ Routine Therapy DRUG

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.

Also known as: Gushen Juanyu Formula+ACEI/ARB

Group A; Group B

Routine Therapy DRUG

Patients receive a stable dose of ACEI/ARB drug as a routine therapy.

Also known as: ACEI/ARB

Group A; Group B

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Anhui Provincial Children's Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Children's Hospital of Nanjing Medical University: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shandong Provincial Hospital: collaborator
• Xuzhou Children Hospital: collaborator

Study Sites (9)

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Location

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangzhou, China

Location

Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital

Zhengzhou, Henan, China

Location

Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology.

Wuhan, Hubei, China

Location

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Shandong Provincal Hospital

Shandong, Shandong, China

Location

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Xuzhou Children's Hospital

Xuzhou, China

Location

MeSH Terms

Conditions

Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Xu, PhD

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: September 17, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)