Primary IgA Nephropathy
Conditions
Interventions
Research Group:Targeted Delayed-Release Budesonide Capsules Combined with SGLT2 Inhibitors
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients aged>=18 years, regardless of gender. 2.Primary IgA nephropathy confirmed by renal biopsy with a duration of = 1 g, or urine protein-to-creatinine ratio (UPCR)>= 0.8 g/g (>=90 mg/mmol). 5.35<= eGFR <= 90 mL/min/1.73m^2; 6.Patients must be willing and able to provide written informed consent at screening.
Exclusion criteria
Exclusion criteria: 1.Renal transplant recipients. 2.Patients with systemic diseases that can cause IgA deposition in the glomerular mesangium, including but not limited to allergic purpura, systemic lupus erythematosus, dermatitis herpetiformis, and ankylosing spondylitis. 3.Patients with other glomerular diseases (e.g., C3 glomerulopathy and/or diabetic nephropathy) and those with nephrotic syndrome (defined as proteinuria > 3.5 g/day and serum albumin = 140 mmHg or diastolic blood pressure >=90 mmHg are ineligible. At least one blood pressure measurement during Study Visit 1 or Study Visit 3 should fall within these limits (a maximum of 3 measurements, taken at 1-minute intervals after resting in a supine position for at least 5 minutes). 8.Patients with Type 1 diabetes or poorly controlled Type 2 diabetes (defined as HbA1c > 8% [64 mmol/mol]). 9.Patients diagnosed with malignancies within the past 5 years, excluding treated basal cell carcinoma, effectively excised squamous cell carcinoma of the skin, colon polyps, or in situ cervical cancer. 10.Patients with known intermediate or high-risk osteoporosis, based on the recommendations of the American College of Rheumatology from 2010. In Chinese patients, intermediate or high-risk status is defined according to the Osteoporosis Self-Assessment Tool for Asians (OSTA) index. 11.Patients with known glaucoma, known cataracts, and/or those who have undergone cataract surgery, unless both eyes have been operated on. 12.Gastrointestinal diseases that may interfere with the efficacy of the investigational drug or the release of the drug (e.g., peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea). 13.Patients with a known allergy to the investigational drug. 14.Patients with a history of severe adverse reactions to corticosteroids, including psychiatric symptoms, as determined by the investigator. 15.Patients who have received immunosuppressive therapy, excluding GCS, within the 12 months prior to randomization. 16.Patients who have received any GCS treatment within 3 months prior to randomization. 17.Patients who have received any systemic GCS within 12 months prior to randomization, except in cases where the dosage is equivalent to or less than 0.5 mg/kg/day of prednisone for non-IgAN indications, with a maximum of 3 courses (each course lasting 2 weeks). 18.Patients currently taking strong inhibitors of cytochrome P450 3A4 (CYP3A4). 19.Patients with a current or past history (within the last 2 years) of alcohol or substance abuse. 20.Patients who have ingested any investigational drug within 30 days prior to randomization and at least 5 half-lives prior to that. 21.Patients who are unwilling or unable to adhere to the requirements specified in the proto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPCR ratio;Occurrence of adverse events and serious adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-Average Proteinuria;Average UPCR, UACR, and eGFR; | — |
Countries
China
Contacts
Public ContactWei Chen
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed