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

Sponsor
University Medical Center Groningen
Study ID
NCT05268926
Phase
PHASE2
Status
Terminated

Conditions

  • Albuminuria

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 3, 2022
Status verified
Apr 2024
Primary completion
Feb 2, 2023
Completion
Feb 2, 2023

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Dapagliflozin 10mg/day

Primary Outcome Measure

urinary albumin/creatinine ratio [ Time Frame: 24 weeks ]

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