NCT00312780已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study of XL784 Administered Orally to Subjects With Albuminuria Due to Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 44
- 主要终点
- Reduction in albumin excretion relative to creatinine
研究概览
简要总结
This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL784 when given daily to patients with albuminuria due to diabetic nephropathy. XL784 is a small molecule reno-protective metalloproteinase inhibitor, inhibiting both ADAMs (including ADAM10, a target of significant interest because of its important role in blood vessel formation and cell proliferation, and ADAM17/TACE, activation of which has been associated with renal deterioration) and MMPs (including MMP-2 and MMP-9). XL784 was specifically optimized to be MMP-1 sparing, which may be clinically significant because inhibition of MMP-1 has been hypothesized to be associated with musculoskeletal toxicity.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes mellitus with albuminuria, observed within 3 months of screening
- •Prior to randomization, subject has a glomerular filtration rate (GFR) >/= 40 mL/min
- •Prior to randomization, the subject has albuminuria defined as ACR >/= 500 mg/g
- •Stable seated blood pressure at the screening visit and prior to randomization
- •Subject has been on a stable dose and schedule of an angiotension converting enzyme (ACE) inhibitor and/or an angiotension receptor blocker (ARB) for at least 3 months before first dose of study drug
- •If on antidiabetic medication, subject has been on a stable dose and schedule for at least 3 months prior to first dose of study drug
- •Sexually active subjects must use an accepted method of contraception during the course of the study and for 3 months after
- •Signed informed consent
排除标准
- •Subject has participated in an investigational study and received an investigational drug within 30 days of the first dose of XL784
- •Hemoglobin A1c (HbA1c) value of >10% at screening
- •Subject has had either organ transplantation or is currently on immunosuppressive therapy
- •Non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days of urine screening assessments
- •Current diagnosis of one or more of the following conditions: 1) infection requiring parenteral antibiotics, 2) urinary tract infection, 3) hepatic dysfunction or disease, 4) symptomatic congestive heart failure, 5) unstable angina pectoris, 5) serious cardiac arrhythmia
- •Clinically evident diabetic gastroparesis or motility disturbance
- •Proteinuria not due to diabetic nephropathy
- •Diltiazem or verapamil
- •Ongoing condition where treatment with NSAIDs is anticipated (aspirin </= 325 mg/day is allowed)
- •Recent history of drug or alcohol abuse
- •Pregnant or breastfeeding female subjects
- •Known HIV and/or receiving anti-retroviral therapy
- •Known allergy or hypersensitivity to any component of XL784 formulation
研究组 & 干预措施
Arm 1: XL784
Experimental
干预措施: XL784 (Drug)
Arm 2: Placebo Gel capsules
Placebo Comparator
干预措施: XL784 (Drug)
结局指标
主要结局
Reduction in albumin excretion relative to creatinine
时间窗: 27 weeks
次要结局
- Safety and tolerability(27 weeks)
- Pharmacokinetics and renal elimination(27 weeks)
研究者
研究点 (44)
Loading locations...
相似试验
已完成
2 期
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary SyndromeAcute Coronary SyndromeNCT00548587Eisai Inc.600
已完成
1 期
A Study of RO5095932 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2NCT00961909Hoffmann-La Roche122
Unknown
3 期
Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque PsoriasisPsoriasisPlaque PsoriasisNCT02701205Shanghai Celgen Bio-Pharmaceutical Co.,Ltd216
终止
1 期
A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and ComorbiditiesB-Cell Chronic Lymphocytic LeukemiaNCT02336048Hoffmann-La Roche38
撤回
2 期
A Study of RO5036505 in Patients With Moderate to Severe AsthmaAsthmaNCT00967590Hoffmann-La Roche