Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorbent Therapeutics
ClinicalTrials.gov Identifier:
NCT01598740
First received: May 11, 2012
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure
Interventions: Drug: CLP
Drug: Spironolactone

  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
The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.

Reporting Groups
  Description
CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days) Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days) Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.

Participant Flow for 2 periods

Period 1:   Period 1
    CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)     CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     0     0  

Period 2:   Period 2
    CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)     CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)  
STARTED     8 [1]   9  
COMPLETED     7     9  
NOT COMPLETED     1     0  
[1] 1 subject discontinued during the washout period prior to starting treatment period 2.



  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
CLP + Spiro/CLP Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
CLP/CLP + Spiro Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
Total Total of all reporting groups

Baseline Measures
    CLP + Spiro/CLP     CLP/CLP + Spiro     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 7.58     63.4  ± 9.77     59.9  ± 8.7  
Gender  
[units: participants]
     
Female     4     1     5  
Male     5     8     13  
Weight  
[units: kg]
Mean ± Standard Deviation
  91.35  ± 24.20     99.54  ± 27.49     95.4  ± 25.8  
Diet  
[units: participants]
     
Low sodium     1     2     3  
Medium sodium     1     1     2  
High sodium     7     6     13  



  Outcome Measures
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1.  Primary:   Change in Fecal Sodium Content   [ Time Frame: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) ]

2.  Secondary:   Change in Fecal Weight   [ Time Frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) ]


  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
Organization: Sorbent Therapeutics, Inc.
phone: 858-405-1429
e-mail: hdittrich@sorbent.com


No publications provided


Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01598740     History of Changes
Other Study ID Numbers: CTST-25
Study First Received: May 11, 2012
Results First Received: March 22, 2013
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration