Status:
TERMINATED
TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
AstraZeneca
Conditions:
Albuminuria
Eligibility:
All Genders
45-80 years
Phase:
PHASE2
Brief Summary
Rationale: Increased albuminuria has a relatively high prevalence in the general population (5-9%) People with increased albuminuria are more likely to develop progressive kidney and cardiovascular d...
Eligibility Criteria
Inclusion
- Age 45 to 80 years
- Persistent urinary albumin:creatinine ratio (UACR) ≥ 2.5 mg/mmol (\~25 mg/g)
- Willing to sign informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05268926
Start Date
February 3 2022
End Date
February 2 2023
Last Update
April 17 2024
Active Locations (1)
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1
UMCG
Groningen, Netherlands