The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor \[ACEi\] or Angiotensin-receptor blockers \[ARB\]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio \[UACR\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Film-coated tablet
Film-coated tablet
Film-coated tablet
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Kolding Sygehus
Kolding, Denmark
Bispebjerg og Frederiksberg Hospital
København NV, Denmark
Copenhagen University Hospital, Rigshospitalet
København Ø, Denmark
HOP d'Angers
Angers, France
HOP Michallon
Percentage of patients with drug related Adverse Events (AEs)
Time frame: Up to 35 days
Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in morning void urine
Time frame: Up to 28 days
Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (10-hour) urine
Time frame: Up to 28 days
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La Tronche, France
HOP Bichat
Paris, France
HOP la Milétrie
Poitiers, France
HOP Nord Laënnec
Saint-Herblain, France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
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