Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Pharmaterra
Information provided by (Responsible Party):
Sorbent Therapeutics
ClinicalTrials.gov Identifier:
NCT01265524
First received: December 20, 2010
Last updated: March 12, 2013
Last verified: March 2013
Results First Received: January 3, 2013  
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: Prevention
Condition: Heart Failure
Interventions: Drug: CLP
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Although 113 subjects were randomized, 2 subjects did not receive study drug and were removed from the analysis as pre- specified in the SAP.

Reporting Groups
  Description
Investigational Drug: CLP Investigational drug: 15 g CLP per day given as capsules
Placebo Placebo: capsules

Participant Flow:   Overall Study
    Investigational Drug: CLP     Placebo  
STARTED     59     52  
COMPLETED     41     46  
NOT COMPLETED     18     6  



  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
Investigational Drug: CLP Investigational drug: 15g CLP per day given as capsules
Placebo Placebo: capsules
Total Total of all reporting groups

Baseline Measures
    Investigational Drug: CLP     Placebo     Total  
Number of Participants  
[units: participants]
  59     52     111  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  68  ± 8     70  ± 10     69  ± 9  
Gender  
[units: participants]
     
Female     17     23     40  
Male     42     29     71  
Weight  
[units: kg]
Mean ± Standard Deviation
  75.3  ± 13.6     75.1  ± 16.2     75.2  ± 14.9  
eGFR  
[units: ml/min/1.73m3]
Mean ± Standard Deviation
  45.0  ± 14.2     44.9  ± 17.3     45  ± 15.8  
New York Heart Association (NYHA) Functional Class [1]
[units: participants]
     
II     0     2     2  
III     52     45     97  
IV     7     5     12  
[1] NYHA Functional Classes are I, II, III, and IV A brief summary of the classes is included below. Class I: patients with cardiac disease but without resulting limitations of physical activity Class II: patients with cardiac disease with slight limitations to physical activity Class III: patients with cardiac disease with marked limitations of physical activity Class IV: patients with cardiac disease resulting in an inability to carry out physical activity without discomfort



  Outcome Measures
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1.  Primary:   Change in Serum Potassium   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Weight Loss at Week 1   [ Time Frame: Baseline and 1 week ]

3.  Secondary:   Weight Loss at Week 2   [ Time Frame: Baseline and 2 weeks ]

4.  Secondary:   Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4   [ Time Frame: 4 weeks ]

5.  Secondary:   Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8   [ Time Frame: 8 weeks ]

6.  Secondary:   Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8   [ Time Frame: Baseline and 8 weeks ]

7.  Secondary:   6MWT Distance at Week 8   [ Time Frame: Baseline and 8 weeks ]


  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: Howard Dittrich, MD FACC
Organization: Sorbent Therapeutics
phone: 858-405-1429
e-mail: hdittrich@sorbent.com


Publications of Results:

Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01265524     History of Changes
Other Study ID Numbers: CTST-21
Study First Received: December 20, 2010
Results First Received: January 3, 2013
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration
Armenia: Ministry of Health
Georgia: Ministry of Health
Moldova: Ministry of Health