Effect of a Carbonaceous Oral Adsorbent on the Progression of CKD: A Multicenter, Randomized, Controlled Trial
Received 2 September 2008; accepted 13 May 2009. published online 21 July 2009.
Background
The carbonaceous oral adsorbent AST-120 slows the deterioration of kidney function in patients with advanced chronic kidney disease (CKD). However, information about AST-120 in patients with less severe stages of CKD is lacking.
Study Design
Randomized controlled trial.
Setting & Participants
75 medical facilities, 460 patients with CKD with serum creatinine (sCr) concentrations less than 5.0 mg/dL (not undergoing dialysis).
Intervention
Random assignment to either a low-protein diet and antihypertensive medication in the control group or that treatment combined with AST-120 (6 g/d).
Outcomes & Measurements
Composite primary end point: doubling of sCr level, increase in sCr level to 6.0 mg/dL or more, need for dialysis or transplantation, or death. Secondary outcomes: adverse events and changes in estimated creatinine clearance (CCr) rate, proteinuria (protein in milligrams per day), and quality of life.
Results
Mean sCr level was 2.66 mg/dL and estimated CCr was 22.4 mL/min in both groups. During 56 weeks, numbers of primary end-point events (43 for control versus 42 for AST-120) and event-free survival (P = 0.9) did not differ between groups. Gastrointestinal adverse events were less common in the control group than the AST-120 group (2 versus 32 events). Estimated CCr decreased more in the control group than in the AST-120 group (−0.15 versus −0.12 mL/min/y; P = 0.001). Median proteinuria changed from protein of 1,162 to 1,167 mg/d in the control group versus 1,102 to 906 mg/d in the AST-120 group (P = 0.2).
Limitation
Infrequent primary end-point events.
Conclusion
AST-120 did not substantially slow the progression of kidney disease in patients with moderate to severe CKD during 1 year.
1Department of Nephrology, Showa University School of Medicine, Tokyo, Japan
2Department of Internal Medicine, Koga Red Cross Hospital, Koga, Japan
3Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, Kyoto, Japan
4Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto and Tokyo, Japan
5Department of Psychology, Faculty of Sociology, Kansai University, Osaka, Japan
6Niigata University Graduate School of Medical and Dental Sciences, Niigata City, Japan
7Nagoya University Graduate School of Medicine, Nagoya, Japan
8Department of Advanced Nephrology, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan
9National Graduate Institute for Policy Studies, Tokyo, Japan
Address correspondence to Shunichi Fukuhara, MD, DMSc, Department of Epidemiology and Healthcare Research, Graduate School of Medicine and Public Health, Kyoto University, Yoshida Konoemachi, Sakyo-ku, Kyoto, 606 8501, Japan
A list of the members of the Carbonaceous Oral Adsorbent's Effects on Progression of Chronic Kidney Disease (CAP-KD) Study Group appears at the end of this article.
ABSTRACT