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Recruiting NCT06676007

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

— Observational IgA Nephropathy (IgAN) Early Initial Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gd-IgA1 test.
Who it may be relevant to
Registry conditions: IgA Nephropathy (IgAN), Early Initial Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other Gd-IgA1 test
    collect and test Gd-IgA1 test in enrolled subjects

Primary outcome measures

  • The changes in proteinuria levels [Time frame: about 12 months]
  • Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. [Time frame: about 12 months]
Secondary outcome measures (7)
  • Evaluate the changes in eGFR of target patients at the 12th month compared to baseline [Time frame: about 12 months]
  • Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline [Time frame: about 12 months]
  • Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients [Time frame: about 12 months]
  • Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month [Time frame: about 12 months]
  • Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month [Time frame: about 12 months]
  • Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month [Time frame: about 12 months]
  • Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month [Time frame: about 12 months]

Eligibility criteria

Inclusion criteria

  • 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
  • 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
  • Sign informed consent

Exclusion criteria

  • 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;
  • Expected lifespan<5 years
  • 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)
  • Researchers believe that patients who are not suitable for treatment with Nefecon

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Sichuan Provincial People's Hospital — Chengdu

Identifiers

NCT: NCT06676007 · NEF-EM-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗