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NCT07901764

MYTP01 for Immune-Mediated Diseases

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change.

  1. Start date pushed from Oct 2026 to Dec 2026
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Change in Estimated Glomerular Filtration Rate (eGFR)
Timeframe: Baseline, Week 4, Week 8, and Week 12
Change in 24-Hour Urinary Protein Excretion
Timeframe: Baseline, Week 4, Week 8, and Week 12
Change in Traditional Chinese Medicine Syndrome Score
Timeframe: Baseline, Week 4, Week 8, and Week 12

Secondary (8)

Change in T-Lymphocyte Subsets
Change in Urine Protein-to-Creatinine Ratio (UPCR)
Change in Urinary Red Blood Cell Count
Change in Serum Albumin Level
Change in Inflammatory Cytokine Levels
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Change in Serum Creatinine Level
Change in Blood Urea Nitrogen Level
Number of Participants With Adverse Events

Arms and interventions

Kidney Transplant Recipients + MYTP01Experimental

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.

Kidney Transplant Recipients + PlaceboPlacebo 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.

IgA Nephropathy + MYTP01Experimental

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.

IgA Nephropathy + PlaceboPlacebo 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.

Drugs: MYTP01, MYTP01 Placebo

Sites

1 site in 1 country

  • Zhejiang Provincial People's HospitalHangzhou, Zhejiang, China