Status:
COMPLETED
Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN
Lead Sponsor:
Ruijin Hospital
Conditions:
Primary IgA Nephropathy
Eligibility:
All Genders
18+ years
Brief Summary
This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-w...
Detailed Description
Currently, TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity. Results from part A of the Phase III clinical trial (NCT03643965) show that com...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥18 years;
- Primary IgA nephropathy confirmed by renal biopsy;
- Stable use of RAS blockers;
- 24-hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol);
- eGFR ≥30 mL/min/1.73m².
Exclusion
- Systemic diseases that may cause interstitial IgA deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis;
- Patients who have received kidney transplants;
- Those with other glomerular diseases (such as C3 glomerular disease or diabetic nephropathy) and nephrotic syndrome;
- Patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
- Patients with cirrhosis or severe liver function impairment, as assessed by the investigator;
- Patients diagnosed with poorly controlled type 1 or type 2 diabetes;
- Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or arrhythmia as assessed by the investigator;
- Patients with poorly controlled blood pressure with systolic or diastolic blood pressure ≥140mmHg or 90mmHg. At least one blood pressure measurement should be in the above range (based on up to three measurements, 1 minute apart, taken after resting in the supine position for at least 5 minutes);
- Patients diagnosed with malignancy within the last 5 years, with the exception of treated basal cell carcinoma of the skin, curably resected squamous cell carcinoma of the skin, polyps of the colon, or carcinoma in situ of the cervix;
- Patients with osteoporosis who are known to be at moderate or high risk. Chinese patients are defined according to the Asian Osteoporosis Self-Assessment Tool (OSTA) Index;
- Patients with known glaucoma, known history of cataract and/or cataract surgery that may interfere with study drug action or release (such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea);
- Patients who are allergic to budesonide or any component of the investigational drug formulation;
- Patients who have previously had a severe adverse reaction to steroids;
- Patients with psychotic symptoms;
- Have received any systemic glucocorticoid therapy within 3 months prior to medication;
- Received immunosuppressants or biologics within 3 months prior to medication;
- Patients taking potent inhibitors of the cytochrome P450 3A4 enzyme (CYP3A4);
- Current or former (within the last 2 years) alcohol or drug abuse;
- Patients who are unwilling or unable to meet program requirements;
- Life expectancy \<5 years;
- Women who are pregnant, nursing, or unwilling to use contraception during treatment.
Key Trial Info
Start Date :
April 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06589752
Start Date
April 24 2023
End Date
September 5 2024
Last Update
September 19 2024
Active Locations (1)
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1
Ruijin hospital
Shanghai, China, 200025