Microalbuminuria MedDRA version: 20.1 Level: PT Classification code 10027525 Term: Microalbuminuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 45 to 80 years • Persistent urinary albumin:creatinine ratio (UACR) = 2.5 mg/mmol (~25 mg/g) • Willing to sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: • Diagnosis of type 1 diabetes mellitus • eGFR 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-angiotensin-aldosterone-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: o History of active inflammatory bowel disease within the last six months; o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; o Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; o Pancreatic injury or pancreatitis within the last six months; o 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; o 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria. ;Secondary Objective: To assess effects of dapagliflozin compared to placebo on the following parameters: o Systolic and diastolic blood pressure o Body weight o Hba1c o eGFR o Proportion of patients with =30%, 40%, 50% reduction in UACR from baseline at week 24. To assess the safety of dapagliflozin;Primary end point(s): Change in first morning UACR from baseline;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes from baseline in: • Systolic / diastolic blood pressure • Body weight • Hba1c • eGFR • Number of patients with =30%, 40%, 50% reduction in UACR from baseline at week 24 ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Netherlands
Contacts
Public ContactH.J. Lambers Heerspink
University Medical Center Groningen
Outcome results
None listed