NCT06796660Not yet recruitingEarly phase 1
Exploring the Impact of Nephropathy Formula No. 1 on Chronic Kidney Disease Patients
Exploring the Impact of Nephropathy Formula No. 1 on T-Cell Immune Balance in Chronic Kidney Disease Patients Via the IL-6/STAT3 Signaling Pathway
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a prospective randomized controlled trial, enrolling 70 patients with CKD stages 2-4, randomly divided into a control group and a treatment group, with 35 cases in each group. The study subjects are sourced from three centers. The control group receives integrated basic treatment for chronic kidney disease, including dietary nutrition adjustment, blood pressure control, blood sugar control, lipid control, anemia treatment, and regulation of water, electrolyte, and acid-base metabolic balance. The treatment group, in addition to the basic treatment, is administered Nephropathy Formula No. 1 orally, with a treatment course of 12 weeks and a follow-up period of 2 weeks. The outcome measures are the changes in biochemical indicators, inflammatory factors, T cell subsets, STAT3 mRNA expression, and TCM syndrome scores after 12 weeks of treatment, to assess therapeutic efficacy. This study proposes the experimental hypothesis that Nephropathy Formula No. 1 can effectively improve the T cell immune balance in CKD patients by modulating the IL-6/STAT3 signaling pathway, thereby inhibiting the occurrence and development of renal fibrosis and improving the prognosis of CKD to a certain extent. Specifically, Nephropathy Formula No. 1 may function through the following mechanisms: (1) downregulating IL-6 mRNA expression, reducing IL-6 secretion, and thereby inhibiting the activation of the STAT3 signaling pathway; (2) regulating the balance of Th17/Treg cell subsets, promoting the differentiation of Th17 cells into Treg cells, enhancing the anti-inflammatory and immunosuppressive effects of Treg cells, and alleviating renal inflammatory responses and fibrosis. Through in-depth exploration of this study, it is expected to provide new ideas and methods for the clinical treatment of CKD, with significant scientific and clinical implications.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Liu Zhanghong
- Diseases
- Chronic kidney disease
- NCT number
- NCT06796660
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 70
- From 1 Sept 2025 to the primary completion date, 1 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have participated in other drug tests within the past three months or have not completed the effective drug washout period. -
Other illness
- Patients with severe primary diseases of the cardiovascular, hematological, digestive, nervous, respiratory, endocrine systems, malignant tumors, etc.;
- Patients in the active phase of autoimmune system diseases;
- Patients with chronic infectious diseases such as active viral hepatitis, HIV, or active tuberculosis;
- Patients with recent acute infections, and non-infectious complications such as hypertension and anemia that have not been effectively controlled;
- Patients who have undergone surgery, trauma, major bleeding, or blood transfusion within the past three months, or have severe clinical infections, electrolyte disturbances, and acid-base imbalances that have not been effectively controlled;
- Patients with mental disorders or poor compliance who cannot cooperate;
Other
- Patients undergoing hemodialysis or peritoneal dialysis;
- Patients who have taken traditional Chinese medicine related to nephropathy treatment within the past month;
- Pregnant or breastfeeding women;
Who the study is looking for
- Age between 18 and 65 years old (inclusive);
- No gender restriction;
- Patients diagnosed with CKD stages 2-4 according to the above diagnostic criteria by a specialist physician;
- TCM syndrome differentiation is consistent;
- Able to cooperate with the study treatment and follow-up, and has good compliance;
- Agree and sign the medical informed consent form.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Third Affiliated Hospital of Zhejiang Chinese Medical University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Wenzhou TCM Hospital of Zhejiang Chinese Medical University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Wenzhou TCM Hospital of Zhejiang Chinese Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.