Prospective randomized controlled study for the therapeutic effect of removing uremic toxins on endothelial function in undialyzed patients with chronic renal failure

UMIN ID: UMIN000001379

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Undialyzed patients with chronic renal failure
• Date of first enrollment: 2009/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treated by AST-120 6g daily for a period of 6 months
Not treated by AST-120 for a period of 6 months

Outcome(s)

• Primary Outcome: Flow-mediated vasodilation of branchial artery
• Secondary Outcome: Changes of the below parameters: (1) Systolic and diastolic blood pressure (2) Creatinine clearance (Ccr) (3) Urinary protein excretion (UPE) (4) Mediators associated with endothelial function

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Patients with obstructive or stenotic diseases of digestive organs. (2) Patients with the nephrotic syndrome. (3) Patients with acute renal failure, rapid elevation of serum creatinine or active nephropahty in the last 6 months. (4) Patients with inflammatory or consumptive diseases (e.g. infection, malignancy). (5) Patients with severe cardiovascular diseases (e.g. heart failure, coronary disease, cerebrovascular disease, peripheral vascular disease). (6) Dialyzed patients. (7) Patients treated by AST-120. (8) Patients treated by steroids or immunosuppressive agents. (9) Females in pregnancy. (10) Patients judged as unsuitable for participating in this study by the attending physician.

Related Information

• Primary Sponsor: Division of Nephrology, Department of Internal Medicine, Kawasaki Medical School
• Secondary Sponsor: None
• Source(s) of Monetary Support: None,None