Last updated: April 15, 2024
Sponsor: University Medical Center Groningen
Overall Status: Terminated
Phase
2
Condition
Vascular Diseases
Williams Syndrome
Stress
Treatment
Dapagliflozin 10Mg Tab
Placebo
Clinical Study ID
NCT05268926
2021/1001
2021-004073-31
Ages 45-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion
Exclusion Criteria: 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 theskin.
- Initiation or changes in the dose of interventions in therenin-angiotensinaldosterone- system, diuretics, GLP-1 receptor agonists within 6weeks of screening will not be allowed.
- Any medication, surgical or medical condition which might significantly alter theabsorption, distribution, metabolism, or excretion of medications including, but notlimited to any of the following:
- History of active inflammatory bowel disease within the last six months;
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, orbowel resection;
- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within lastsix months;
- Pancreatic injury or pancreatitis within the last six months;
- Evidence of hepatic disease as determined by any one of the following: ALT or ASTvalues exceeding 3x ULN at the screening visit, a history of hepaticencephalopathy, a history of esophageal varices, or a history of portocavalshunt;
- 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 orvolume depletion that may affect the interpretation of efficacy or safety data
- Participation in any clinical intervention study within 3 months prior to initialdosing.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence ofsuch abuse as indicated by the laboratory assays conducted during the screening.
- History of noncompliance to medical regimens or unwillingness to comply with the studyprotocol.
- Any surgical or medical condition, which in the opinion of the investigator, may placethe patient at higher risk from his/her participation in the study, or is likely toprevent the patient from complying with the requirements of the study or completingthe study.
- Pregnancy or breastfeeding
Study Design
Total Participants: 9
Treatment Group(s): 2
Primary Treatment: Dapagliflozin 10Mg Tab
Phase: 2
Study Start date:
February 03, 2022
Estimated Completion Date:
February 02, 2023
Connect with a study center
UMCG
Groningen,
NetherlandsSite Not Available

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