Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Medical Center Groningen
With
AstraZeneca
Age
45–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 45 to 80 years
Persistent urinary albumin:creatinine ratio (UACR) ≥ 2.5 mg/mmol (\~25 mg/g)
Willing to sign informed consent
You may not be if
Diagnosis of type 1 diabetes mellitus
eGFR \< 25 ml/min/1.73m2
UACR \> 3500 mg/g
Concurrent treatment with SGLT2 inhibitor
Receiving immunosuppressive therapy within 6 months prior to enrolment
History of diabetic ketoacidosis
Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
Initiation or changes in the dose of interventions in the renin-angiotensinaldosterone- system, diuretics, GLP-1 receptor agonists 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 or difficulty in voiding at screening
History of severe hypersensitivity or contraindications to dapagliflozin
Subjects 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 intervention study within 3 months 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
Clareo Health | TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
