NCT01399580已完成2 期
A Phase 2b, Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy
AbbVie (prior sponsor, Abbott)28 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 28
- 主要终点
- Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
研究概览
简要总结
Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study. The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose) compared to placebo in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled daily dose of a RAS inhibitor.
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
- •Subject is greater than or equal to 18 years old.
- •Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Period.
- •Subject is currently receiving an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB) (Renin Angiotensin System (RAS) inhibitor).
- •If female, subject is not breastfeeding and is not pregnant (verified by negative serum pregnancy test prior to the Treatment Period). Subject is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and practicing one of the approved methods of birth control as defined in the Clinical Trial Protocol. Contraception must be used during the study and for 4 weeks after the last dose of study drug.
- •For entry into the Run-in Period the subject must satisfy the following criteria based on the Screening laboratory values:
- •Estimated glomerular filtration rate (eGFR) greater than or equal to 30 and less than or equal to 75 mL/min/1.73m^2 by the Epidemiology Collaboration (EPI) formula
- •Urinary Albumin to Creatinine Ratio (UACR) greater than or equal to 300 and less than or equal to 3500 mg/g as determined by the geometric mean of the two morning void urine specimens obtained at the Screening visit
- •Serum albumin greater than or equal to 3.0 g/dL
- •B-Type Natriuretic Peptide (BNP) less than or equal to 200 pg/mL
- •Negative serum pregnancy test for female subjects
- •Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 180 mmHg
- •Glucosylated hemoglobin (HbA1c) less than or equal to 12%
- •For entry into the Treatment Period the subject must satisfy the following criteria based on the last visit of the Run-in Period laboratory values:
- •Renin Angiotensin System (RAS) inhibitor at maximum tolerated labeled dose for the previous 4 weeks with no adjustment of dose
- •Diuretic at any dose unless medically contraindicated (with the exception of loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide)
- •UACR ≥ 200 mg/g as determined by the median of the three morning void urine specimens obtained prior to the Week -1 visit
- •Systolic Blood Pressure (SBP) greater than or equal to 110 mmHg and less than or equal to 160 mmHg
- •Serum Potassium less than or equal to 5.5 mEq/L
- •Negative serum pregnancy test for female subjects
排除标准
- •Patient has a history of moderate or severe edema, facial edema unrelated to trauma, or a history of myxedema in the prior 6 months to Screening.
- •Subject is receiving loop diuretics greater than or equal to 120 mg QD of furosemide or greater than or equal to 3.0 mg QD of bumetanide or greater than or equal to 150 mg QD of ethacrynic acid or greater than or equal to 60 mg QD of torasemide.
- •Subject has a history of pulmonary edema.
- •Subject has a history of pulmonary hypertension, or any lung diseases requiring oxygen therapy (i.e., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
- •Subject has a history of orthostatic hypotension within the past 6 months as defined by the presence of a supine-to-standing blood pressure decrease greater than or equal to 20 mmHg systolic or greater than or equal to 10 mmHg diastolic within 3 minutes of standing.
研究组 & 干预措施
Group C - High dose Atrasentan QD
Active Comparator
干预措施: Atrasentan (Drug)
Group A - Placebo QD
Placebo Comparator
干预措施: Placebo (Drug)
Group B - Low dose Atrasentan QD
Active Comparator
干预措施: Atrasentan (Drug)
结局指标
主要结局
Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
时间窗: Every two weeks for 8 weeks
次要结局
- Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)(Every two weeks for 8 weeks)
- The change from baseline to each post-baseline assessment of thoracic bioimpedance(Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
2 期
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical StudyOnychomycosisNCT02933879Taro Pharmaceuticals USA184
已完成
2 期
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03703102Kyowa Kirin, Inc.274
终止
2 期
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous UrticariaChronic Spontaneous UrticariaNCT06077773Escient Pharmaceuticals, Inc113
已完成
2 期
A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)Atopic DermatitisNCT04530643Shaperon80
已完成
2 期
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute BronchitisAcute BronchitisNCT02637310PharmaKing108