A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

This study has been completed.
Sponsor:
Collaborator:
Kureha Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00500682
First received: July 11, 2007
Last updated: March 2, 2015
Last verified: March 2015
Results First Received: February 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Interventions: Drug: Placebo
Drug: AST-120

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AST-120 AST-120: 9g /day (3 times a day)
Placebo Placebo: 9g /day (3 times a day)

Participant Flow:   Overall Study
    AST-120     Placebo  
STARTED     510     510  
COMPLETED     204     223  
NOT COMPLETED     306     287  
Adverse Event                 37                 29  
Death                 25                 16  
Lost to Follow-up                 11                 11  
Physician Decision                 6                 10  
Pregnancy                 2                 0  
Protocol Violation                 1                 3  
Withdrawal by Subject                 80                 74  
Reaching endpoints, Noncompliance, etc                 144                 144  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AST-120 AST-120: 9g /day (3 times a day)
Placebo Placebo: 9g /day (3 times a day)
Total Total of all reporting groups

Baseline Measures
    AST-120     Placebo     Total  
Number of Participants  
[units: participants]
  510     510     1020  
Age  
[units: years]
Mean (Standard Deviation)
  56.5  (14.93)     55.8  (14.99)     56.1  (14.95)  
Gender  
[units: participants]
     
Female     195     179     374  
Male     315     331     646  



  Outcome Measures

1.  Primary:   Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.   [ Time Frame: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint ]

2.  Primary:   Safety and Tolerability   [ Time Frame: approximately 42 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function   [ Time Frame: approximately 42 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Vitamins and Folate Levels   [ Time Frame: approximately 42 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00500682     History of Changes
Other Study ID Numbers: KRM-306
Study First Received: July 11, 2007
Results First Received: February 15, 2015
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ukraine: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
Mexico: National Institute of Public Health, Health Secretariat
Poland: Ministry of Health
Brazil: National Health Surveillance Agency