American Journal of Kidney Diseases
Volume 54, Issue 3 , Pages 459-467, September 2009

Effect of a Carbonaceous Oral Adsorbent on the Progression of CKD: A Multicenter, Randomized, Controlled Trial

  • Tadao Akizawa, MD, PhD

      Affiliations

    • Department of Nephrology, Showa University School of Medicine, Tokyo, Japan
  • ,
  • Yasushi Asano, MD, PhD

      Affiliations

    • Department of Internal Medicine, Koga Red Cross Hospital, Koga, Japan
  • ,
  • Satoshi Morita, PhD

      Affiliations

    • Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  • ,
  • Takafumi Wakita, MS

      Affiliations

    • Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto and Tokyo, Japan
    • Department of Psychology, Faculty of Sociology, Kansai University, Osaka, Japan
  • ,
  • Yoshihiro Onishi, PhD, MPH

      Affiliations

    • Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto and Tokyo, Japan
  • ,
  • Shunichi Fukuhara, MD, DMSc

      Affiliations

    • Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, Kyoto, Japan
    • Corresponding Author InformationAddress 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
  • ,
  • Fumitake Gejyo, MD, PhD

      Affiliations

    • Niigata University Graduate School of Medical and Dental Sciences, Niigata City, Japan
  • ,
  • Seiichi Matsuo, MD, PhD

      Affiliations

    • Nagoya University Graduate School of Medicine, Nagoya, Japan
  • ,
  • Noriaki Yorioka, MD, PhD

      Affiliations

    • Department of Advanced Nephrology, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan
  • ,
  • Kiyoshi Kurokawa, MD

      Affiliations

    • National Graduate Institute for Policy Studies, Tokyo, Japan
  • ,
  • CAP-KD Study Group

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.

Index Words: Randomized controlled trial, carbonaceous oral adsorbent, chronic kidney disease (CKD)

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 Originally published online as doi: 10.1053/j.ajkd.2009.05.011 on July 21, 2009.

 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.

 Trial registration: www.ClinicalTrials.gov; study number: NCT00456859.

PII: S0272-6386(09)00834-8

doi:10.1053/j.ajkd.2009.05.011

Refers to erratum:

  • Errata

    American Journal of Kidney Diseases March 2010 (Vol. 55, Issue 3, Page 616)

American Journal of Kidney Diseases
Volume 54, Issue 3 , Pages 459-467, September 2009