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AzTrials

ProteinuriaNCT05759754

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

A study testing TCM+ Routine Therapy and Routine Therapy in people with Proteinuria and Kidney Diseases, run by Children's Hospital of Fudan University at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 18 years
What is being tested?
TCM+ Routine Therapy and Routine Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
9 sitesChina
Study dates
17 Sep 2023to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangzhou

  • The Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Anhui Provincial Children's Hospital

    Hefei, Anhui

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Shandong Provincal Hospital

    Shandong, Shandong

  • Children's Hospital of Fudan University

    Shanghai, 201102

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

    Wuhan, Hubei

  • Xuzhou Children's Hospital

    Xuzhou

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

    Zhengzhou, Henan

Other trials in China

About this study

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, Crossover Randomized Clinical Trial

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.

Read the detailed 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, 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.

Being tested
TCM+ Routine Therapy, Routine Therapy
Keywords
Traditional Chinese Medicine, anti-proteinuric
Medical subject headings
Proteinuria, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCM+ Routine TherapyDrug

    Also called Gushen Juanyu Formula+ACEI/ARB

    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 TherapyDrug

    Also called ACEI/ARB

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

Study groups in NCT05759754
Study groupRoleWhat they receive
Group AExperimentalTCM+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.
Receives: Drug: TCM+ Routine Therapy; Drug: Routine Therapy
Group BExperimentalRoutine 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.
Receives: Drug: TCM+ Routine Therapy; Drug: Routine Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, week 12, week 14, week 26

  2. 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.

    Measured: baseline, week 12, week 14, week 26

  3. 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.

    Measured: baseline, week 12, week 14, week 26

  4. 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.

    Measured: baseline, week 12, week 14, week 26

Secondary outcomes (4)

  1. 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.

    Measured: baseline, week 12, week 14, week 26

  2. 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.

    Measured: Baseline, week 26

  3. 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

    Measured: baseline, week 12, week 14, week 26

  4. 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

    Measured: baseline, week 12, week 14, week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start17 Sep 2023
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759754
Sponsor's protocol ID
TCMinpKD
Status last verified
Jan 2025
First submitted
26 Feb 2023
Last updated
20 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TCM+ Routine Therapy and Routine Therapy in people with Proteinuria and Kidney Diseases, run by Children's Hospital of Fudan University at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in urinary protein-creatinine ratio (UPCR) from baseline to week 26 (time frame: baseline, week 12, week 14, week 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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