Type 2 Diabetes Mellitus With Kidney Complications Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled, Parallel, Multicenter Study of the Effects of 12-weeks of Sodium Zirconium Cyclosilicate (Lokelma) on Albuminuria (UACR) in Patients With Type 2 Diabetes and Hyperkalemia
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.
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