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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER150 | Experimental | Randomized participants will receive SER150, 15 mg, orally, BID (except on Day 168 where participants will only receive a 15 mg single dose (QD) in the morning) |
|
| Placebo | Placebo Comparator | Randomized participants will receive matching placebo, orally, BID (except on Day 168 where participants will only receive a 15 mg single dose (QD) in the morning) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SER150 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 168 |
| Time to change of eGFRcrea and eGFRcys ≥ 0.50 mL/min/1.73 m^2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| The AIM Centre (Hunter Diabetes Centre) |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo | Drug | 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) |
|
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. |
| 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. | 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. | Baseline to Day 168 |
| 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. | 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. | 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. | D7, D28, D56, D84, D112, D140 and D168 |
| Merewether |
| New South Wales |
| Australia |
| Royal North Shore Hospital | Saint Leonards | New South Wales | 2065 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Southern Adelaide Diabetes and Endocrine Services | Adelaide | South Australia | 5046 | Australia |
| SA Endocrine Research | Keswick | South Australia | 5035 | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Sunshine Hospital | Saint Albans | Victoria | 3021 | Australia |
| Pacific Clinical Research Clinic Rotorua | Rotorua | Bay of Plenty | 3010 | New Zealand |
| PCRN Silverdale Medical Centre | Silverdale | Hibiscus Coast | 0932 | New Zealand |
| Lakeland Clinical Trials Waikato | Hamilton | Waikato Region | 3200 | New Zealand |
| New Zealand Clinical Research (NZCR) | Christchurch | 8011 | New Zealand |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |