This study is to assess the efficacy and safety of SER150 administered for 24 weeks as a 15 mg twice a day BID dose (except on Day 168 15 mg QD) in participants with type 2 diabetes (T2D) and albuminuria in treatment with either an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor antagonist (ARB).
This is a randomized, double-blind, placebo-controlled, parallel groups, multicenter pivotal study assessing the efficacy and safety of 15 mg BID (except on Day 168 15 mg QD) of SER150 in well-controlled adult T2D participants with stable concomitant medications, diabetic kidney disease (DKD) and albuminuria in treatment with an ACEi or an ARB. The randomized treatment period will be 24 weeks followed by a 4-weeks follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Dosage Level(s): 30 mg (1 capsule of 15 mg twice a day - morning and evening) (except on Day 168 where participants will only receive a single dose (QD) in the morning)
Dosage Level(s): Matched placebo (1 capsule twice a day - morning and evening) (except on Day 168 where participants will only receive a single dose (QD) in the morning)
Liverpool Hospital
Liverpool, New South Wales, Australia
The AIM Centre (Hunter Diabetes Centre)
Merewether, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168
The efficacy of 15 mg BID of SER150 with placebo will be compared in well controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: Baseline to Day 168
Change of UACR from Baseline to Day 168
Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: Baseline to Day 168
Time to change of eGFRcrea and eGFRcys ≥ 0.50 mL/min/1.73 m^2
Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB. eGFRcrea is defined as estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation and eGFRcys is defined as estimated glomerular filtration rate using the CKD-EPI cystatin C equation.
Time frame: Baseline to Day 168
Number of participants with a change in eGFRcrea and eGFRcys
Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: Baseline to Day 168
Number of participants with a change in eGFRcr-cys
Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB. eGFRcr-cys is defined as estimated glomerular filtration rate using CKD-EPI creatinine-cystatin C equation.
Time frame: Baseline to Day 168
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Princess Alexandra Hospital
Brisbane, Queensland, Australia
Southern Adelaide Diabetes and Endocrine Services
Adelaide, South Australia, Australia
SA Endocrine Research
Keswick, South Australia, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Pacific Clinical Research Clinic Rotorua
Rotorua, Bay of Plenty, New Zealand
PCRN Silverdale Medical Centre
Silverdale, Hibiscus Coast, New Zealand
...and 2 more locations
Number of participants with end stage renal disease, any serious cardiovascular events (stroke-acute myocardial infarction-cardiovascular death) and all-cause mortality
Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196)
Number of participants with adverse events (AEs)
Safety/tolerability of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196)
PK trough SER150 concentrations (pre-dose)
Efficacy, Safety/tolerability of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.
Time frame: D7, D28, D56, D84, D112, D140 and D168