EUCTR2005-004990-13-ES进行中（未招募）1 期
Estudio en fase III, aleatorizado, doble ciego y controlado con placebo de AST-120 para la prevención de la progresión de la Enfermedad Renal Crónica en pacientes con Enfermedad Renal Crónica moderada o grave que incluirá la valoración de la calidad de vida
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •Patients that meet all of the following Inclusion Criteria may be enrolled into the study:
- •1) Age 18 years or older;
- •2) Moderate to severe CKD (sCr = 2.0 mg/dL[= 177 µmol/L] and = 5.0 mg/dL[= 442 µmol/L]), not anticipated to require dialysis or renal transplant within the next 6 months;
- •3) Patient survival expected to be no less than one year;
- •4) Serum creatinine = 2.0 mg/dL [= 177 µmol/L] and = 5.0 mg/dL [= 442 µmol/L] at the initial Screening visit;
- •5) Proteinuria / Progressive deterioration in renal function:
- •Urinary total protein to urinary total creatinine ratio (both values measured as mg/dL, or other like units) must be = 0.5 on a spot void obtained at the Screening visit
- •If the urinary total protein to urinary total creatinine ratio is <0.5, then the patient may return for a second Screening visit 3 months later. If the sCr value at the second Screening visit is >10% higher than the first Screening visit but not > 5.0 mg/dL [= 442 µmol/L] or if the urinary total protein to urinary total creatinine ratio is = 0.5, then the patient may be enrolled.
- •6) Sitting blood pressure < 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg;
- •7) In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen, defined as no changes in anti-hypertensive medications or doses in the last 3 months prior to the Baseline visit, and to include a stable dose of either an ACEI or ARB unless contraindicated;
- •8) Stable nutritional status; and
- •9) Willingness to comply with the study and sign a written informed consent.
- •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
- •Patients that meet any of the following Exclusion Criteria must not be enrolled into the study:
- •1) Obstructive or reversible cause of kidney disease;
- •2) Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine (both components measured as mg/dL or other like units) of > 6.0 as measured on a spot void;
- •3) Adult polycystic kidney disease;
- •4) History of previous kidney transplant;
- •5) History of alcohol or drug abuse within the past 12 months;
- •6) Known human immunodeficiency virus (HIV) infection;
- •7) Received immunosuppressive therapy (including systemic corticosteroids for more than 5 days at a daily dose in excess of 0.1 mg/kg, prednisone equivalent) in the past 3 months, or anticipated to require such treatment during the study course;
- •8) History of recent (within the past 6 months) accelerated or malignant hypertension;
- •9) Patients who are likely to require changes in ACEI or ARB regimens during the course of this study;
- •10) Uncontrolled arrhythmia or severe cardiac disease (New York Heart Association Class III -IV), including myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack within the past 6 months;
- •11) History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder;
- •12) History of cancer within the past 5 years (cervical carcinoma in situ, low-grade cutaneous malignancy, or other low grade malignancy are exemptions);
- •13) Alanine transaminase (ALT) or aspartate transaminase (AST) values > 2.5 times the upper limit of normal (ULN);
- •14) Received any investigational agent or participated in a clinical study within the previous 3 months;
- •15) Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study; or
- •16) For women of childbearing potential, a positive pregnancy test result of serum beta human chorionic gonadotropin (ßHCG) or unwillingness to use approved single barrier or oral contraception, or unwillingness to be sexually abstinent.
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