Renal Impairment Clinical Trial
Official title:
A Phase I, Open Label, Parallel Group, Multi-center Single Dose Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36
This is a multi center, open label, parallel group, single administration, phase I trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.
Current diabetes therapy does not stop progression of the disease and the development of
diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal
impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has
been established that chronic (sub)clinical inflammation is crucial for the onset and
progression of DM.
CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the
cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte
emigration from the bone marrow, activates monocytes and macrophages and directs their
migration to sites of inflammation. Recent animal studies and clinical trials indicate a
critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a
potential target for therapeutic intervention in DM. Finally, protein overload and oxidative
challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli,
thereby accelerating the progression of diabetic nephropathy.
As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to
evaluate the role of renal impairment for adequate dosing recommendations in the planned
target population.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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