Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
DW1029M 150mg 2 tablets b.i.d
DW1029M 300mg 2 tablets b.i.d
Placebo 2 tablets b.i.d.
DongWha Pharm
Seoul, Seoul, South Korea
log ACR
logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks
Time frame: 24 weeks after 1st administration
Log UAE
Urinary Albumin Excretion(UAE) after 12 and 24 weeks
Time frame: 24 weeks after 1st administration
eGFR
estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks
Time frame: 12 and 24 weeks after 1st administration
log ACR
logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks
Time frame: 12 weeks after 1st administration
SCC
Serum Creatinine Concentration(SCC) after 12 and 24 weeks
Time frame: 12 and 24 weeks after 1st administration
Cystatin C
Cystatin C after 12 and 24 weeks
Time frame: 12 and 24 weeks after 1st administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.