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:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT05283057
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 and ≤75 years.
2. Urinary protein excretion \> 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
3. On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
4. Who signed informed consent.
5. Women of Child-Bearing Potential (WOCBP) used an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy was minimized.
Exclusion Criteria:
* a) Diagnosis of type 1 or type 2 diabetes mellitus b) Urinary protein excretion of less than 500 mg/g and eGFR \< 30 ml/min
* 1.7m2 c) Active malignancy d) Any medication, surgical or medical condition that may 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.
e) 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.
f) Evidence of urinary tract obstruction. g) History of hypersensitivity or contraindications to empagliflozin. h) 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.
i) Participation in any clinical investigation within 3 months prior to initial dosing.
j) History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
k) Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05283057
Study Brief:
Protocol Section:
NCT05283057