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
- Conditions
- Enfermedad Renal Crónica Moderada o GraveMedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease
- Registration Number
- EUCTR2005-004990-13-ES
- Lead Sponsor
- Kureha Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
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
OR
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method