IgA NephropathyNCT07901764
MYTP01 for Immune-Mediated Diseases
A study testing MYTP01 in people with IgA Nephropathy and Kidney Transplant Recipients, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy, Kidney Transplant Recipients, Lupus Nephritis
- What is being tested?
- MYTP01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Zhejiang Provincial People's Hospital, +86-571-85893830, zhejiangvip1234@163.com
About this study
Official title: A Multicenter, Prospective Basket Clinical Trial of AI-Selected Traditional Chinese Medicine for Immune-Mediated Diseases and Investigation of Its Immunomodulatory Mechanisms
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?
Read more
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.
- Conditions
- IgA Nephropathy, Kidney Transplant Recipients, Lupus Nephritis, Primary Membranous Nephropathy, ANCA-associated Vasculitis, Systemic Lupus Erythematosus
- Being tested
- MYTP01, MYTP01 Placebo
- Keywords
- IgA Nephropathy, Kidney Transplant Recipients, ANCA-Associated Vasculitis, Lupus Nephritis, Primary Membranous Nephropathy, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's Syndrome, Hashimoto Thyroiditis
- Medical subject headings
- Glomerulonephritis, IGA, Lupus Nephritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Sjogren's Syndrome, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYTP01Drug
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.
MYTP01 PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients + MYTP01 | Experimental | 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. Receives: Drug: MYTP01 |
| Kidney Transplant Recipients + Placebo | Placebo comparator | 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. Receives: Drug: MYTP01 Placebo |
| IgA Nephropathy + MYTP01 | Experimental | 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. Receives: Drug: MYTP01 |
| IgA Nephropathy + Placebo | Placebo comparator | 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. Receives: Drug: MYTP01 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Week 4, Week 8, and Week 12
Change in 24-Hour Urinary Protein Excretion
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Traditional Chinese Medicine Syndrome Score
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (8)
Change in T-Lymphocyte Subsets
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Urine Protein-to-Creatinine Ratio (UPCR)
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Urinary Red Blood Cell Count
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Serum Albumin Level
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Inflammatory Cytokine Levels
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Serum Creatinine Level
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Blood Urea Nitrogen Level
Measured: Baseline, Week 4, Week 8, and Week 12
Number of Participants With Adverse Events
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zengyuqun, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901764
- Sponsor's protocol ID
- KT2025324
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Basket Clinical Trial of AI-Selected Traditional Chinese Medicine for Immune-Mediated Diseases and Investigation of Its Immunomodulatory Mechanisms
- ClinicalTrials.gov ID
- NCT07901764
- Acronym / sponsor ID
- KT2025324
- Conditions
- IgA Nephropathy, Kidney Transplant Recipients, Lupus Nephritis, Primary Membranous Nephropathy, ANCA-associated Vasculitis, Systemic Lupus Erythematosus
- Keywords
- IgA Nephropathy, Kidney Transplant Recipients, ANCA-Associated Vasculitis, Lupus Nephritis, Primary Membranous Nephropathy, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients + MYTP01 | Experimental | Drug: MYTP01Kidney 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. |
| Kidney Transplant Recipients + Placebo | Placebo comparator | Drug: MYTP01 PlaceboKidney 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. |
| IgA Nephropathy + MYTP01 | Experimental | Drug: MYTP01Patients 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. |
| IgA Nephropathy + Placebo | Placebo comparator | Drug: MYTP01 PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MYTP01MYTP01 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 | IgA Nephropathy + MYTP01, Kidney Transplant Recipients + MYTP01 |
| MYTP01 PlaceboMYTP01 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. | Drug | IgA Nephropathy + Placebo, Kidney Transplant Recipients + Placebo |
Primary outcome
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in 24-Hour Urinary Protein Excretion
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Traditional Chinese Medicine Syndrome Score
Time frame: Baseline, Week 4, Week 8, and Week 12
8 secondary outcomes
Change in T-Lymphocyte Subsets
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Urine Protein-to-Creatinine Ratio (UPCR)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Urinary Red Blood Cell Count
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Serum Albumin Level
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Inflammatory Cytokine Levels
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Serum Creatinine Level
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Blood Urea Nitrogen Level
Time frame: Baseline, Week 4, Week 8, and Week 12
Number of Participants With Adverse Events
Time frame: Baseline through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MYTP01 in people with IgA Nephropathy and Kidney Transplant Recipients, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqun Zeng (+86-15058153877, zengyuqun401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Estimated Glomerular Filtration Rate (eGFR) (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.