Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy

Launched by NANJING CHIA-TAI TIANQING PHARMACEUTICAL · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NTQ5082 for people with primary IgA nephropathy, a kidney condition that can affect how well the kidneys work. The goal is to see if NTQ5082 is effective in improving kidney function and is safe for patients. Participants in this trial will be adults aged 18 and older, who have been diagnosed with primary IgA nephropathy and meet certain health criteria, such as having a specific level of protein in their urine and a stable kidney function.

If you or someone you know qualifies and decides to join, you will take NTQ5082 capsules and be monitored for their effects and any side effects. It’s important to note that participants need to be on certain blood pressure medications and must use effective birth control during the trial. The study is not yet recruiting, but it aims to help improve treatment options for this kidney disease, so it's a valuable opportunity to contribute to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, male or female.
• • 2. Body weight ≥40 kg, BMI between 15 to 38 kg/m².
• • 3. Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.
• • 4. 24-hour urine protein excretion (24h-UPE) ≥0.75 g/24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g/g.
• • 5. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m².
• • 6. Previously vaccinated with ACYW135 meningococcal polysaccharide vaccine and pneumococcal vaccine.
• • 7. Received renin-angiotensin system (RAS) inhibitor therapy for at least 12 weeks prior to randomization, with stable treatment at the maximum recommended dose or maximum tolerated dose of RAS inhibitors for at least 4 weeks prior to randomization.
• • 8. Agreement to use at least one effective contraceptive method with partners during sexual activity from signing the informed consent form until 4 weeks after the last administration of the investigational product, and refrain from sperm/egg donation during this period.
• Exclusion Criteria:
• • 1. Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
• • 2. Continuous use of systemic corticosteroids, immunosuppressants/modulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
• • 3. Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.
• • 4. History of gastrointestinal surgery potentially altering drug absorption/distribution/metabolism/excretion, severe gastrointestinal disorders, or conditions causing dysphagia/recurrent vomiting that may interfere with oral medication intake.
• • 5. Major trauma/surgery within 12 weeks before screening or planned major surgery during the study.
• • 6. Previous bone marrow/hematopoietic stem cell transplantation or solid organ transplantation (e.g., heart, lung, kidney, liver).
• • 7. Known/suspected hereditary complement deficiency, or diagnosed primary/severe secondary immunodeficiency.
• • 8. Poorly controlled blood pressure as assessed by the investigator.
• • 9. Poorly controlled blood glucose as assessed by the investigator.
• • 10. Presence of nephrotic syndrome, rapidly progressive glomerulonephritis, renal pathology showing \>50% glomerular crescents, or \>50% tubular atrophy-interstitial fibrosis.
• • 11. Participation in other interventional clinical trials with pharmacological/device interventions within 4 weeks before screening.
• • 12. Pregnant/lactating women or those planning pregnancy during the study