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NCT07901764

MYTP01 for Immune-Mediated Diseases

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate whether MYTP01, a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI), is effective and safe as an additional treatment for immune-mediated diseases (post-kidney transplantation, IgA nephropathy, etc.). The study also aims to explore whether MYTP01 may provide therapeutic benefits across these conditions by regulating shared immune and inflammatory processes. The main questions this study aims to answer are: * Does MYTP01 provide clinical benefits and remain safe when used as an additional treatment for immune-mediated conditions? * Does MYTP01 help regulate immune balance and inflammatory responses across immune-mediated disease populations? Researchers will compare MYTP01 with a matching placebo, with both treatments given in addition to standard medical care, to evaluate clinical efficacy, safety, and potential immunomodulatory effects across immune-mediated conditions. Participants will: * Be enrolled in a disease-specific cohort based on their clinical condition. * Be randomly assigned to receive either MYTP01 or placebo in addition to their usual medical treatment. * Take the assigned study treatment twice daily for 8 weeks. * Attend follow-up visits approximately once a month during a 12-week study period. * Undergo clinical assessments, blood and urine tests, and evaluations of immune function and possible side effects.

Official title: A Multicenter, Prospective Basket Clinical Trial of AI-Selected Traditional Chinese Medicine for Immune-Mediated Diseases and Investigation of Its Immunomodulatory Mechanisms

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-10

Completion Date

2028-12

Last Updated

2026-11-02

Healthy Volunteers

Conditions

IgA Nephropathy Kidney Transplant Recipients Lupus Nephritis Primary Membranous Nephropathy ANCA-associated Vasculitis Systemic Lupus Erythematosus Rheumatoid Arthritis (RA)Sjogren's Syndrome Hashimoto Thyroiditis

Interventions

DRUG

MYTP01

MYTP01 is a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI). It is administered orally as granules twice daily for 8 weeks in addition to standard medical treatment.

DRUG

MYTP01 Placebo

MYTP01 placebo is provided as oral granules designed to match MYTP01 in appearance and packaging to maintain blinding. It is administered twice daily for 8 weeks in addition to standard medical treatment, including immunosuppressive therapy as prescribed.

Inclusion Criteria: * Adults aged 18 to 65 years. * Diagnosed with one of the following conditions: (1) Kidney transplant recipients: At least 6 months after kidney transplantation, with stable graft function (eGFR variation \<20% and no recent acute rejection). (2) IgA nephropathy: Biopsy-confirmed primary IgA nephropathy within the past 5 years, with persistent disease activity despite at least 3 months of supportive treatment (UPCR 0.5-3.5 g/day and eGFR ≥ 30 mL/min/1.73 m²). * Stable immunosuppressive or other background medical treatment for at least 4 weeks before enrollment, with dose changes ≤ 20%. * Adequately controlled blood pressure (≤140/90 mmHg) and fasting blood glucose (≤6.1 mmol/L), with stable vital signs. * Willing to receive Chinese herbal treatment and undergo scheduled follow-up assessments, including T-cell subset analysis, cytokine measurements, and renal function tests. * Traditional Chinese medicine (TCM) syndrome differentiation consistent with the indications for the AI-selected herbal formula. * Female participants who are not pregnant and agree to use effective contraception during the study. * Willing and able to provide written informed consent. Exclusion Criteria: * Acute transplant rejection within the past 3 months or rapidly progressive IgA nephropathy (eGFR decline ≥30%). * Severe renal impairment (eGFR \<30 mL/min/1.73 m²) or requiring dialysis. * Severe proteinuria (\>3.5 g/day) or nephrotic syndrome. * Active infections, including opportunistic infections, active hepatitis B or C infection, or active tuberculosis. * Initiation or major dose adjustment of immunosuppressants, biologic agents, or corticosteroids, or antibiotic treatment within the past 4 weeks. * History of malignancy within the past 5 years. * Severe cardiovascular, hepatic, hematologic, or psychiatric disorders that may affect study participation or adherence. * Known allergy or hypersensitivity to any component or excipient of the study herbal formula. * Pregnant or breastfeeding women, or women planning to become pregnant during the study period. * Participation in another clinical trial during the study period.

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China