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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
dapagliflozin 10 mg/d or matched placebo
Placebo
UMCG
Groningen, Netherlands
urinary albumin/creatinine ratio
Change in albuminuria defined as urinary albumin/creatinine ratio: UACR) with dapagliflozin 10mg/d for 24 weeks relative to placebo
Time frame: 24 weeks
systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure: effect of dapagliflozin 10mg/d compared to placebo on change in systolic and diastolic blood pressure
Time frame: 24 weeks
body weight
change in body weight: effect of dapagliflozin 10mg/d compared to placebo on change in body
Time frame: 24 weeks
HbA1c
change in HbA1c: effect of dapagliflozin 10mg/day compared to placebo on change in HbA1c
Time frame: 24 weeks
eGFR
change in eGFR: effect of dapagliflozin 10mg/day compared to placebo on change in eGFR
Time frame: 24 weeks
change in UACR
difference in proportion of patients with ≥30%, 40%, 50% change in UACR from baseline at week 24.: effect of dapagliflozin 10mg/day compared to placebo on the proportion of patients with ≥30%, 40%, 50% change in UACR
Time frame: 24 weeks
number of SAE's and AE's
Safety of dapagliflozin vs Placebo: number of SAE's and AE's reported by the subject or investigator if qualified as: reason for discontinuation, volume depletion, fracture, diabetic ketoacidosis, amputation and adverse events leading to amputation, urinary tract infection, genital infections and hypoglycemia
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.