Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT06686758
Eligibility Criteria:
Inclusion Criteria
1. Age ≥18 years.
2. Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.
3. HbA1c ≤9% at screening.
4. Elevated albuminuria defined as either: uACR ≥30 mg/g on ≥2 occasions within 3 months or sustained proteinuria \>300 mg/24-hour urine collection.
5. eGFR ≥60 mL/min/1.73 m² (CKD-EPI equation) at baseline.
6. Stable RAS blockade therapy meeting either: Maximum tolerated dose of ACE inhibitor/ARB for ≥4 weeks pre-screening or documented intolerance to ACEi/ARB (with nephrologist confirmation).
7. If using SGLT2 inhibitors and/or nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs): stable regimen ≥4 weeks pre-enrollment or commitment to maintain dosing throughout study.
8. Capacity to provide written informed consent (self or via legally authorized representative).
Exclusion Criteria
1. Type 1 diabetes or secondary diabetes.
2. Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.
3. Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).
4. Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).
5. patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.
6. patients with a history of malignancy within 5 years.
7. participation in other clinical studies within 3 months.
8. Pregnant or lactating women.
9. hypersensitivity to any of the components of the interventions in this study.
10. alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06686758
Study Brief:
Protocol Section:
NCT06686758