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

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

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy (IgAN); Early Initial Therapy
• Intervention / Treatment: Other: Gd-IgA1 test

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Guisen Li, Doctor; Phone Number: +86-28-87393340; Email: guisenli@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure<140/90mmHg

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in proteinuria levels	To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline	about 12 months
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.	Safety event	about 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the changes in eGFR of target patients at the 12th month compared to baseline	about 12 months
Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline	about 12 months
Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients	about 12 months
Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month	about 12 months
Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month	about 12 months
Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month	about 12 months
Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month	about 12 months

Other Outcome Measures

Outcome Measure	Time Frame
Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline.	about 12 months

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: multi-center; IgA Nephropathy (IgAN); Nefecon; Early Initial Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: NEF-EM-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No