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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: 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
• Treatments: Angiotensin-Converting Enzyme Inhibitors

Criteria

Inclusion Criteria:

• Aged 6-18 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;

• Serum albumin is above 25g/L;

• Estimated GFR ≥ 60 ml/min/1.73m2 (estimated with Schwartz formula);

• Without any immunosuppressive medications such as corticosteroids, CNIs, 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 CAKUT, NPHP, ADPKD, or ARPKD, etc;

• With abnormal liver function, ALT or AST >2.0 x upper limit of normal (ULN) at enrolment;

• Receiving immunosuppressive therapy (including corticosteroids, and other immune suppressive medicine) within three months prior to enrolment;

• 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.