EUCTR2005-002095-15-ES进行中（未招募）1 期
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic NephropathyThe Collaborative Study Group Trial: El efecto de Sulodexide en la Nefropatia Diabética manifiesta Tipo 2. - Sulodexide in Overt Type 2 Diabetic Nephropathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The patient must be diagnosed with type 2 diabetes:
- •2.The patient must be diagnosed with diabetic nephropathy as defined by PCR of three first void AM urine samples equal to or greater than 900 mg/G in woman and 650 mg/G in men at Visit 2. Serum creatinine in woman between 1.3 and 3.0 mg/dL, inclusive, and men between 1.5 and 3.0 mg/dL, inclusive, at Visit 1. If the screening serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-un Period if the GFR by the MDRD formula at Visit 1 is between 25 to 45 mL/min.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Type 1 (insulin-dependent; juvenile onset) diabetes;
- •2.Renal disease as follows:
- •Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable), or
- •Renal allograft;
- •3.Absolute requirement for combination therapy of Angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin receptor blocker (ARB);
- •4.Cardiovascular disease as follows:
- •Unstable angina pectoris within 3 months of study entry;
- •Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry;
- •Transient ischemic attack within 3 months of study entry;
- •Cerebrovascular accident within 3 months of study entry;
- •New York Heart Association Functional Class III or IV (Note: if a patient is New York Heart Association Functional Class I or II and requires an ACEI, consult with the Clinical Coordinating Center to obtain permission for the patient to be on an ACEI rather than an ARB);
- •Obstructive valvular heart disease or hypertrophic cardiomyopathy; or
- •Second or third degree atrioventricular block not successfully treated with a pacemaker;
- •5.Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids (excluding inhaled or nasal steroids);
- •6.Known allergies or intolerance to any heparin-like compound including heparin-induced thrombocytopenia Type II;
- •7.Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
- •8.Untreated urinary tract infection or other medical condition that may impact urinary protein values.
研究者
相似试验
进行中（未招募）
不适用
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic NephropathyOvert Type 2 Diabetic NephropathyMedDRA version: 8.0Level: LLTClassification code 10061835EUCTR2005-002095-15-SEKeryx Biopharmaceuticals, Inc.2,240
进行中（未招募）
不适用
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic NephropathyOvert Type 2 Diabetic NephropathyMedDRA version: 8.0Level: LLTClassification code 10061835EUCTR2005-002095-15-BEKeryx Biopharmaceuticals, Inc.2,240
进行中（未招募）
不适用
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic NephropathyOvert Type 2 Diabetic NephropathyMedDRA version: 8.0Level: LLTClassification code 10061835EUCTR2005-002095-15-DKKeryx Biopharmaceuticals, Inc.2,240
进行中（未招募）
不适用
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic NephropathyOvert Type 2 Diabetic NephropathyMedDRA version: 8.0Level: LLTClassification code 10061835EUCTR2005-002095-15-GBKeryx Biopharmaceuticals, Inc.2,240
进行中（未招募）
不适用
The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy - Sulodexide in Overt Type 2 Diabetic NephropathyOvert Type 2 Diabetic NephropathyMedDRA version: 8.0Level: LLTClassification code 10061835EUCTR2005-002095-15-HUKeryx Biopharmaceuticals, Inc.2,240