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Not yet recruitingNCT07901764Updated Nov 4, 2026

MYTP01 for Immune-Mediated Diseases

An interventional study of MYTP01 and MYTP01 Placebo in IgA Nephropathy, Kidney Transplant Recipients and Lupus Nephritis, sponsored by Zhejiang Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Start date movedPrimary outcomes revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
Read the detailed description

This study is designed to evaluate the clinical value of MYTP01, a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI), as an adjunct to standard medical treatment for representative immune-mediated conditions (post-kidney transplantation, IgA nephropathy, etc.). The study aims to investigate whether MYTP01 may provide therapeutic benefits across different immune-mediated conditions by modulating shared immune and inflammatory processes.

The trial adopts a multicenter, randomized, double-blind, placebo-controlled basket design. Approximately 160 participants are enrolled into two disease-specific cohorts based on their clinical conditions. After screening and baseline assessments, eligible participants within each cohort are randomly assigned in a 1:1 ratio to receive either MYTP01 or a matching placebo in addition to standard medical treatment.

All participants continue their standard medical treatment, including immunosuppressive therapy as prescribed, throughout the study period. Participants receive oral MYTP01 or placebo twice daily for 8 weeks, followed by continued follow-up until approximately Day 90. Clinical assessments are performed at predefined time points to monitor clinical outcomes, immune function, and treatment safety.

Clinical efficacy is evaluated through changes in estimated glomerular filtration rate (eGFR), 24-hour urinary protein excretion, and traditional Chinese medicine syndrome scores. Potential immunomodulatory effects are further explored by assessing T-lymphocyte subsets and inflammatory cytokines, including IL-2, IL-6, IL-10, TNF-α, and TGF-β, to investigate immune and inflammatory responses across the representative disease cohorts.

Standardized clinical and laboratory assessments are performed across participating centers to ensure consistency in data collection and outcome evaluation. Safety is continuously monitored through clinical examinations, routine laboratory testing, and the recording of adverse events throughout the treatment and follow-up periods.

The results of this study are expected to provide preliminary clinical evidence regarding the efficacy, safety, and potential immunomodulatory effects of MYTP01 in representative immune-mediated conditions. The findings may also help evaluate the feasibility of AI-assisted traditional Chinese herbal formula development and inform future investigations of shared therapeutic strategies across immune-mediated diseases.

02

Conditions studied

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

Keywords

  • IgA Nephropathy
  • Kidney Transplant Recipients
  • ANCA-Associated Vasculitis
  • Lupus Nephritis
  • Primary Membranous Nephropathy
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Hashimoto Thyroiditis
03

In context

Glomerulonephritis, IGA

266 studies on the registry are indexed under Glomerulonephritis, IGA; 105 are open to participants now.

This study's planned enrollment of 160 is above the median of 68 across 216 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 62 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Kidney Transplant Recipients + MYTP01

    Kidney transplant recipients receive standard medical treatment, including immunosuppressive therapy, plus oral MYTP01 twice daily for 8 weeks, followed by continued follow-up until Week 12.

    Drug: MYTP01

  • Placebo comparator
    Kidney Transplant Recipients + Placebo

    Kidney transplant recipients receive standard medical treatment, including immunosuppressive therapy, plus oral placebo twice daily for 8 weeks, followed by continued follow-up until Week 12.

    Drug: MYTP01 Placebo

  • Experimental
    IgA Nephropathy + MYTP01

    Patients with IgA nephropathy receive standard medical treatment, including immunosuppressive therapy as prescribed, plus oral MYTP01 twice daily for 8 weeks, followed by continued follow-up until Week 12.

    Drug: MYTP01

  • Placebo comparator
    IgA Nephropathy + Placebo

    Patients with IgA nephropathy receive standard medical treatment, including immunosuppressive therapy as prescribed, plus oral placebo twice daily for 8 weeks, followed by continued follow-up until Week 12.

    Drug: MYTP01 Placebo

Interventions

  • DrugMYTP01

    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.

  • DrugMYTP01 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.

06

What researchers measure

Primary outcomes

  1. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, Week 4, Week 8, and Week 12

  2. Change in 24-Hour Urinary Protein Excretion

    Time frame: Baseline, Week 4, Week 8, and Week 12

  3. Change in Traditional Chinese Medicine Syndrome Score

    The Traditional Chinese Medicine Syndrome Score Assessment Scale comprises two categories: deficiency-related and excess-related elements. Each category includes seven items, each scored from 0 to 3, with higher scores indicating more pronounced manifestations of the corresponding element. Scores for each category range from 0 to 21. The highest-scoring element in each category is combined to identify the corresponding traditional Chinese medicine syndrome pattern.

    Time frame: Baseline, Week 4, Week 8, and Week 12

Secondary outcomes

  1. Change in T-Lymphocyte Subsets

    Time frame: Baseline, Week 4, Week 8, and Week 12

  2. Change in Urine Protein-to-Creatinine Ratio (UPCR)

    Time frame: Baseline, Week 4, Week 8, and Week 12

  3. Change in Urinary Red Blood Cell Count

    Time frame: Baseline, Week 4, Week 8, and Week 12

  4. Change in Serum Albumin Level

    Time frame: Baseline, Week 4, Week 8, and Week 12

  5. Change in Inflammatory Cytokine Levels

    Time frame: Baseline, Week 4, Week 8, and Week 12

  6. Change in Serum Creatinine Level

    Time frame: Baseline, Week 4, Week 8, and Week 12

  7. Change in Blood Urea Nitrogen Level

    Time frame: Baseline, Week 4, Week 8, and Week 12

  8. Number of Participants With Adverse Events

    Time frame: Baseline through Week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 28, 2026
StartEst.
Dec 2026was Oct 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 2026→Dec 2026
Nov 4, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Traditional Chinese Medicine Syndrome Score: how it is measured was reworded
Nov 2, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 3 updates
  1. Nov 4, 2026
    Start date Oct 2026→Dec 2026
  2. Nov 2, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Traditional Chinese Medicine Syndrome Score: how it is measured was reworded
    + 1 other change: verification date
  3. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901764
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
zengyuqun (Principal Investigator, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Oct 28, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Yuqun Zeng
Contact
zengyuqun401@163.com
+86-15058153877

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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