A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a medication called budesonide, which comes in special capsules, on patients with a kidney condition known as Primary IgA Nephropathy (IgAN). The goal is to see if starting this treatment early can help improve kidney function and reduce symptoms for patients who have recently been diagnosed. The study is not yet recruiting participants, but it aims to include adults aged 18 to 75 who have been diagnosed with IgAN through a kidney biopsy in the last three months and have specific levels of kidney function and protein in their urine.

To participate, individuals must meet certain criteria, such as having a specific diagnosis and not having other serious health issues. Participants will be asked to provide informed consent, meaning they understand the study and agree to take part. Throughout the trial, participants will receive the medication and be monitored for its effectiveness and any side effects. This study is important because it could provide valuable insights into how early treatment can help manage IgAN and improve patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Target patients aged 18-75, including those aged 18 and 75
• • 2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months
• • 3. eGFR≥30ml/min/1.73m2
• • 4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
• • 5. Sign informed consent
• Exclusion Criteria:
• • 1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
• • 2. Patients who have received kidney transplantation or dialysis
• • 3. Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\>3.5 g/d, serum albumin\<3.0 g/dl, with or without edema)
• • 4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
• • 5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%)
• • 6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
• • 7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
• • 8. Patients diagnosed with malignant tumors within the past 5 years
• • 9. Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
• • 10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
• • 11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
• • 12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
• • 13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
• • 14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
• • 15. Current or previous (within the past 2 years) alcoholism or drug abuse;
• • 16. Expected lifespan\<5 years
• • 17. During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
• • 18. Researchers believe that patients who are not suitable for treatment with Nefecon