NCT07901764
MYTP01 for Immune-Mediated Diseases
Not Yet Recruiting · Not Applicable · Zhejiang Provincial People's Hospital · registry updated 2026-11-04
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
Exclusion
- 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.