Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria

Exclusion Criteria

• •Diagnosis of type 1 or type 2 diabetes mellitus
• •Urinary protein excretion \> 3500 mg/day
• •Peripheral Vascular Disease
• •Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
• •Indication for immunosuppressants as per the treating physician's judgment.
• •Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
• •Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
• •Use of co-interventional treatments (outlined in section 4.2 of the protocol) within 6 weeks of screening will not be allowed.
• •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 of difficulty in voiding at screening
• •History of severe hypersensitivity or contraindications to dapagliflozin
• •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 evidence of such abuse as indicated by the laboratory assays conducted during the screening.
• •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.
• •Pregnancy or breastfeeding
• •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.