A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
研究概览
简要总结
The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.
详细描述
The primary objective is to determine if LY2382770, administered monthly for 1 year, is more effective than placebo at slowing the progression of diabetic kidney disease in participants treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with chronic kidney disease presumed due to diabetes Type 1 or Type 2
- •Participants with certain levels of kidney function - serum creatinine (SCr) 1.3 to 3.3 mg/dl (115 to 291 micromol/L) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309 micromol/L) inclusive for men, or an estimated glomerular filtration rate (eGFR) 20 to 60 mL/min/1.73 m²
- •Participants with protein in the urine - 24-hour urine protein/creatinine ratio (PCR) greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol).
- •Participants must be on a stable and acceptable dose of an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker), or not able to tolerate these medications.
排除标准
- •Female participants who can become pregnant, are pregnant or breastfeeding
- •Participants who have any of the following medical conditions (the site research staff will discuss these criteria and determine a participant's ability to participate)
- •Chronic inflammatory or autoimmune diseases
- •Chronic Kidney Disease from causes other than diabetes
- •An organ transplant
- •Too high a blood pressure
- •Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver disease
- •Recent gastrointestinal bleeding
- •Acute kidney injury within the 3 months before screening
- •Major surgery within 3 months before screening or plan to have it during the study period
- •HIV infection- the virus that causes AIDS
- •Heart disease that is not considered stable
- •Cancer that is too recent or other condition which poses too high a risk for developing cancer
- •Required to take drugs that change the immune system
研究组 & 干预措施
2 mg LY2382770
干预措施: LY2382770 (Drug)
Placebo
干预措施: Placebo (Drug)
10 mg LY2382770
干预措施: LY2382770 (Drug)
50 mg LY2382770
干预措施: LY2382770 (Drug)
结局指标
主要结局
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
时间窗: Baseline, 12 months
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
次要结局
- Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint(Baseline, 12 months)
- Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval(Baseline through 12 months (samples collected pre and/or postdose at monthly intervals))
- Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months(Baseline through 12 months)
- Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months(Baseline through 12 months)