TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension

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

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 disease compared to persons with no albuminuria. ACE-inhibitors or Angiotensin Receptor Blockers are recommended by clinical practice guidelines to lower albuminuria in patients with hypertension and diabetes. However, despite these drugs decrease albuminuria by approximately 30%, elevated albuminuria remains present in the substantial proportion of persons in the general population.

SGLT2 inhibitors are a relatively new class of drugs. Originally they were developed as oral antihyperglycemic drugs. SGLT2 inhibitors have been demonstrated to lower albuminuria and protect the kidney in patients with established chronic kidney disease (CKD) with or without diabetes. Whether the efficacy of SGTL2 inhibitors to lower albuminuria (and possibly confer kidney protection) to persons in the general population (with or without diabetes or hypertension) with persistent albuminuria who generally are at early stages of CKD is unknown.

Objective:

To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria.

Study design:

Randomized placebo-controlled double blind clinical trial of 24 weeks in duration followed by a 4 weeks wash-out period

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,
    Netherlands

    Site Not Available

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