A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
研究概览
简要总结
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
详细描述
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blinded study in which MEDI3506 and placebo. Neither the subject nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects will be aware of the treatment received.
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
干预措施: MEDI3506 (Drug)
Group 1
MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
干预措施: Dapagliflozin (Drug)
Group 2
MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
干预措施: MEDI3506 (Drug)
Group 2
MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
干预措施: Dapagliflozin (Drug)
Group 3
MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
干预措施: MEDI3506 (Drug)
Group 3
MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
干预措施: Dapagliflozin (Drug)
Group 4
MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
干预措施: MEDI3506 (Drug)
Group 4
MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
干预措施: Dapagliflozin (Drug)
Group 5
Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
干预措施: Placebo (Drug)
Group 5
Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
时间窗: From baseline to Day 169
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
次要结局
- Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population(From baseline to Day 85)
- Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population(From baseline to Day 169)
- Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population(From baseline to Day 85)
- Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population(From Day 85 to Day 169)
- Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population(Baseline and Day 169)
- Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population(Day 1 to Day 230)
- Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population(Day 1 to Day 230)
- Immunogenicity of MEDI3506 - PK Analysis Population(Day 1 to Day 230)
- Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population(Baseline and Day 169)