Effects of Traditional Chinese Medicine (GSJYF) in Children With Inherited Proteinuric Kidney Disease
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether traditional Chinese medicine, Gushen Juanyu Formula, as complementary treatment is safe and effective in the treatment of Inherited Proteinuric Kidney Disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Current therapy for inherited protinuric 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.
Our hypothesis is that this traditional Chinese medicine, targeted to podocyte injury and repair named Gushen Juanyu Formula, can significantly reduce proteinuria and delay renal function loss in patients with proteinuric kidney disease. To test this hypothesis, we 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 eGFR during the treatment period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Traditional Chinese Medicine treatment group Patients will receive Gushen Juanyu Formula, 30 ml or 60ml each time based on weight (30 mL for W≤30kg, or 60ml for W>30kg), 2 times a day for 12 weeks, orally, as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker. Patients receiving a stable dose of ACEI/ARB will be continued. |
Drug: TCM+ Routine Therapy
The Gushen Juanyu Formula contains 11 herbs and it is available in liquid form for patients. Patients will receive Gushen Juanyu Formula, 30 ml or 60ml each time based on weight (30 mL for W≤30kg, or 60ml for W>30kg), 2 times a day for 12 weeks, orally, as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker. Patients receiving a stable dose of ACEI/ARB will be continued.
Other Names:
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| Other: Control group Patients receive a stable dose of ACEI/ARB drug as a routine therapy. |
Drug: Routine Therapy
Patients receive a stable dose of ACEI/ARB drug as a routine therapy.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage change in urinary protein-creatinine ratio (UPCR) from baseline to week 12 [baseline, week 4, week 8, 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.
- Changes in estimated glomerular filtration rate (eGFR) from baseline to week 12 [baseline, week 4, week 8, 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.
- Percentage change in urinary albumin-creatinine ratio (UACR) from baseline to week 12 [baseline, week 4, week 8, 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.
- Percentage change in 24-hour protein from baseline to week 12 [baseline, week 4, week 8, week 12]
24-hour urine samples are measured at baseline, week 4, week 8, and week 12. 24-hour proteinuria is a repeated measurement.
Secondary Outcome Measures
- Changes in serum albumin from baseline to week 12 [baseline, week 4, week 8, week 12]
Serum albumin are measured at baseline, week 4, week 8, and week 12. Serum albumin is a repeated measurement.
- Changes of Traditional Chinese Medicine syndrome scores after treatment [Baseline, week 12]
Evaluation of Traditional Chinese Medicine syndromes at baseline, and week 12
- Changes in liver function parameters from baseline to week 12: Alanine Aminotransferase (ALT) [baseline, week 4, week 8, week 12]
Blood samples are measured at baseline, week 4, week 8, week 12 to evaluate ALT
- Changes in liver function parameters from baseline to week 12: Aspartate Aminotransferase (AST) [baseline, week 4, week 8, week 12]
Blood samples are measured at baseline, week 4, week 8, week 12 to evaluate AST
Other Outcome Measures
- Number of subjects reporting adverse events during the treatment period [baseline, week 4, week 8, week 12]
Number of subjects with AEs as a measure of safety
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 6-18 years；
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Proteinuria associated with hereditary nephropathy, which was confirmed by mutations in podocyte genes or syndromal genes (including collagens);
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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;
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Serum albumin is above 25g/L;
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Estimated GFR ≥ 60 ml/min/1.73m2 (estimated with Schwartz formula);
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Without any immunosuppressive medications such as corticosteroids, CNIs, etc；
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On a stable dose of ACEI or ARB for at least 4 weeks；
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Willingness to give written consent and comply with the study protocol.
Exclusion Criteria:
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Diagnosed with CAKUT, NPHP, ADPKD, or ARPKD, etc;
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With abnormal liver function, ALT or AST >2.0 x upper limit of normal (ULN) at enrolment;
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Receiving immunosuppressive therapy (including corticosteroids, and other immune suppressive medicine) within three months prior to enrolment;
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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;
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Has undergone major organ transplantation (e.g. heart, kidney, liver);
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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;
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History of noncompliance to medical regimens or inability to comply with the study and follow-up procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anhui Provincial Children's Hospital | Hefei | Anhui | China | |
| 2 | First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangzhou | China | |
| 3 | Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital | Zhengzhou | Henan | China | |
| 4 | Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology. | Wuhan | Hubei | China | |
| 5 | Children's Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | |
| 6 | Shandong Provincal Hospital | Shandong | Shandong | China | |
| 7 | The Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | |
| 8 | Children's Hospital of Fudan University | Shanghai | China | 201102 | |
| 9 | Xuzhou Children's Hospital | Xuzhou | China |
Sponsors and Collaborators
- Children's Hospital of Fudan University
- Anhui Provincial Children's Hospital
- Henan Provincial People's Hospital
- Wuhan Union Hospital, China
- Children's Hospital of Nanjing Medical University
- The Children's Hospital of Zhejiang University School of Medicine
- First Affiliated Hospital, Sun Yat-Sen University
- Shandong Provincial Hospital
- Xuzhou Children's Hospital
Investigators
- Study Chair: Hong Xu, PhD, Children's Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TCMinpKD