This is a randomized, double-blind, placebo-controlled, parallel groups, multicenter pivotal study assessing the efficacy and safety of 15 mg twice a day (BID) of SER150 in well-controlled adult type 2 diabetic patients with stable concomitant medications, diabetic kidney disease (DKD) and albuminuria in treatment with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor antagonist (ARB). Number of Participants: Assuming a maximum 10% drop-out rate, up to 110 participants will be randomly assigned to study intervention and to achieve 100 evaluable participants for an estimated total of 50 evaluable participants per intervention group. Intervention Groups and Duration: Both the randomized arms will have a treatment period of 24 weeks (dosing period) followed by 4 weeks follow up. Patients will receive investigational medicinal product (IMP) orally (15 mg SER150 or placebo) BID (a single dose will be administered on Day 1). The time difference between the two daily doses will be every 12 hours.
Clinical Trial
Other
Volunteers
Person with early stage kidney disease
Email: thomas.morrish@avancecro.com
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