The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
25 mg BAY1142524 are given twice daily over a treatment period of 6 months
Matching placebo tablets are given twice daily over a treatment period of 6 months
Med Centre Diamedical 2013
Dimitrovgrad, Bulgaria
MCOMH Preventsia-2000
Stara Zagora, Bulgaria
Med. Center Equita
Varna, Bulgaria
Rigshospitalet
Copenhagen, Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Pihlajalinna ITE Kuopio
Kuopio, Finland
Terveystalo Oulu
Oulu, Finland
TAYS TKI Keskus Tutkimusvastaanotto
Tampere, Finland
Turun yliopistollinen keskussairaala, kantasairaala
Turku, Finland
...and 17 more locations
Change in urinary albumin to creatinine ratio (UACR)
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
Time frame: Baseline and at 6 months
Number of patients with treatment-emergent adverse event
Time frame: From first intake of study drug up to 3 days after last administration of study drug
Number of patients with serious adverse events
Time frame: From first intake of study drug up to 3 days after last administration of study drug
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