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

NCT06676007 | Recruiting

• 1 other identifier: NEF-EM-004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy (IgAN); Early Initial Therapy

Keywords

IgA Nephropathy (IgAN); Nefecon; multi-center; Early Initial Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Other Outcomes (1)

• Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline.

  about 12 months

Interventions

Gd-IgA1 test OTHER

collect and test Gd-IgA1 test in enrolled subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Target patients aged 18-75, including those aged 18 and 75
• Primary IgA nephropathy diagnosed by renal biopsy within 3 months
• eGFR≥30ml/min/1.73m2
• hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
• Sign informed consent

You may not qualify if:

• Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
• Patients who have received kidney transplantation or dialysis
• 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)
• Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
• Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%)
• Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
• Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
• Patients diagnosed with malignant tumors within the past 5 years
• Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
• Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
• Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
• Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
• Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
• Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
• Current or previous (within the past 2 years) alcoholism or drug abuse;

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

UPCR, eGFR, blood chemistry, blood routine, urine routine, 24-hour Urine Protein Quantitation, etc..

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Guisen Li, Doctor

CONTACT

+86-28-87393340; guisenli@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology Department

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 6, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)