NCT04881123已完成2 期
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 Type 2 Diabetic Patients With Diabetic Kidney Disease and Albuminuria in Treatment With an Angiotensin Converting Enzyme Inhibitor or an Angiotensin Receptor Antagonist
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Serodus AS
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has had stable T2D for 3 months prior to screening
- •Participant has albuminuria defined by urine UACR ≥ 200 mg/g creatinine as a mean of three independent samples of first urine void of the day
- •Participant is receiving stable antidiabetic treatment. Antidiabetic treatment includes all drugs given for the treatment of T2D
- •Participant is in treatment with ACEi or ARB, with eGFRcrea lower than 75 mL/minute /1.73 m^2 and above 15 mL/minute/1.73 m^2 (CKD-EPI formula) and will not, in the opinion of the investigator, become a candidate for renal dialysis whilst on the study
- •Participant is determined to be overtly healthy as determined by Investigator review of their medical history, physical examination, laboratory tests, and cardiac monitoring. It is anticipated that, whilst some of the participant's results may be different to that of a completely healthy individual, the Investigator will review the participant's individual results to ensure they are as healthy as can be expected give the participant's current health status
- •Participant has ASA physical status, health class 2, 3 or 4
- •Participant has blood pressure ≤ 160 mmHg systolic, and ≤ 100 mmHg diastolic
- •Participant has normal electrocardiogram
- •Participant has glycosylated hemoglobin (HbA1c) ≤ 10%
- •Participant has prothrombin within normal values
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Acute myocardial infarction within the last 3 months
- •Stroke within the last 3 months
- •Any major surgery in the last 3 months that in the opinion of the Investigator poses an increased bleeding risk.
- •ACR ≤ 200 mg/g creatinine
- •Urinary bladder infections within the last 3 months (all other urinary tract infections and vulvovaginitis are excluded)
- •Recent history (within the last 6 months) or ongoing liver disease, including viral infections
- •Participants with HIV
- •Participants with known specific renal diseases different from DKD
- •Any bleeding disorder or acute blood coagulation defect
- •A history of gastric ulcers or any other organic lesion susceptible to bleeding
- •Participant has had a confirmed COVID-19 infection by appropriate laboratory test (PCR or Rapid Antigen Test) within the last 4 weeks prior to screening or on admission
- •Participant who had severe course of COVID-19
- •Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period that, in the opinion of the Investigator, may compromise the safety of the participant in the study, reduce the participant's ability to participate in the study, or interfere with evaluation of the study drug
- •Change in antidiabetic treatment during last 3 months
- •Chronic treatment with nonsteroidal anti-inflammatory drugs or other anti-inflammatory compounds during the last month
- •Treatment with anticoagulant drugs
- •Participation in another clinical trial of an investigational small molecule, antibody (or medical advice) within 30 days (or 5 half-lives of the drug, whichever is longer [if known]) prior to the start of IP administration on Day 2 (or within 6 months prior to the start of IP administration on Day 1 if the investigational drug was a biologic).
- •Alanine aminotransferase or aspartate aminotransferase values exceeding 5 x upper limit of normal (ULN)
- •Alkaline phosphatase and/or total bilirubin values exceeding 1.5 x ULN
- •HbA1c > 10%
- •eGFRcrea ≥75 mL/minute/1.73 m^2 and ≤ 15 mL/minute/1.73 m^2
- •Allergy to the active substance or any of the excipients of the drug product
- •Pregnant or lactating women
研究组 & 干预措施
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)
干预措施: SER150 (Drug)
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)
干预措施: Placebo (Drug)
结局指标
主要结局
A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168
时间窗: 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.
次要结局
- Number of participants with a change in eGFRcrea and eGFRcys(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(Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196))
- Time to change of eGFRcrea and eGFRcys ≥ 0.50 mL/min/1.73 m^2(Baseline to Day 168)
- Number of participants with adverse events (AEs)(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)(D7, D28, D56, D84, D112, D140 and D168)
- Number of participants with a change in eGFRcr-cys(Baseline to Day 168)
- Change of UACR from Baseline to Day 168(Baseline to Day 168)
研究者
研究点 (12)
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