A PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF AST-120 FOR PREVENTION OF CHRONIC KIDNEY DISEASE PROGRESSION IN PATIENTS WITH MODERATE TO SEVERE CHRONIC KIDNEY DISEASE - ND

• Conditions: moderate to severe chronic kidney disease; MedDRA version: 6.1Level: PTClassification code 10038444

• Registration Number: EUCTR2005-004989-17-IT
• Lead Sponsor: KUREHA CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1) Age 18 years or older; 2) Moderate to severe CKD (sCr >= 2.0 mg/dL (>=177 umol/L) and <= 5.0 mg/dL (<= 442 umol/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 umol/L) and <= 5.0 mg/dL (<= 442 umol/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 umol/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 if medically indicated, a stable dose of either an ACEI or ARB; 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

Exclusion Criteria

1) Obstructive or reversible cause of kidney disease; 2) Severe 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, 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);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified