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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT05570305
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 and ≤75 years
* Urinary albumin:creatinine ratio \> 100 mg/g and ≤ 3500 mg/g in a first morning void urine collection
* eGFR ≥ 30 mL/min/1.73m2
* On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
* Willing to sign informed consent
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease
* Hba1c \> 12.5%
* Urinary protein excretion \> 3500 mg/day
* Heart Failure NYHA Class III or IV
* NT-proBNP \> 600 pg/ml
* Hemoglobin \<9g/dL
* Acute coronary syndrome event within the preceding 6 months
* Severe peripheral edema according to investigators opinion
* Women of childbearing potential (WOCBP). WOCBP is defined as women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal
* Pregnancy or breastfeeding
* Indication for immunosuppressants according to Investigator's opinion
* Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin within the last 5 years.
* Use of the co-interventional treatments (outlined in section 5.2) within 6 weeks of screening.
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
* History of active inflammatory bowel disease within the last six months;
* Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
* Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
* Pancreatic injury or pancreatitis within the last six months;
* Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
* Evidence of urinary obstruction or difficulty in voiding at screening
* Severe hepatic impairment
* History of epilepsy syndrome
* History of severe hypersensitivity or contraindications to dapagliflozin
* History of hypersensitivity or contraindications to iodinated contrast media
* Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
* Participation in any clinical investigation within 3 months prior to initial dosing.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing.
* History of drug or alcohol abuse within the 12 months prior to dosing, or according to investigator's assessment.
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05570305
Study Brief:
Protocol Section:
NCT05570305