To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.
Patients with type 2 diabetes and nephropathy, especially patients with impaired kidney function, frequently encounter hyperkalemia as an adverse effect of RAAS blocking treatment. Consequently, RAAS blocking treatment is reduced or discontinued, which in turn impairs prognosis in terms of long-term renal and cardiovascular outcome. Not only can hyperkalemia as an adverse event lead to changes in RAAS blocking treatment, the presence of persistent potassium levels in the upper part of the normal range can impair the efficacy of the RAAS blocking treatment, another reason to expect a beneficial effect of Lokelma treatment. The study is a multicentre (3 sites in Sweden (TBD), 2 sites in Denmark (Steno Diabetes Center Copenhagen and Zealand University Hospital, Roskilde), double-blind, randomized placebo-controlled, parallel study. The study drug is compared to matching placebo that cannot be distinguished from active drug. The treatment period is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Sodium zirconium cyclosilicate (a hyperkalemia treatment)
Matching placebo
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
RECRUITINGUrinary albumin creatinine ratio (UACR)
Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment
Time frame: 12 weeks
Estimated glomerular filtration rate (eGFR)
Change in eGFR mL/min/1.73 m2 (CKD-EPI formula) from baseline to end of treatment
Time frame: 12 weeks
Urinary sodium
Change in urinary sodium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period
Time frame: 12 weeks
Urinary potassium
Change in urinary potassium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period
Time frame: 12 weeks
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