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

May 11, 2012
July 12, 2013
June 2012
September 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Change in fecal sodium content [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01598740 on ClinicalTrials.gov Archive Site
Change in Fecal Weight [ Time Frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) ] [ Designated as safety issue: No ]
Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)
Change in fecal weight [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure

The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Drug: CLP
    Oral administration
  • Drug: Spironolactone
    oral administration
  • Experimental: CLP with spironolactone
    Interventions:
    • Drug: CLP
    • Drug: Spironolactone
  • Experimental: CLP without spironolactone
    Intervention: Drug: CLP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Heart failure with New York Heart Association (NYHA) Classification II or III
  • Chronic kidney disease
  • Cardiac ejection fraction <40%
  • On heart failure therapy including an ACEI or ARB, and a BB
  • Willing to understand and comply with study procedures and provide written informed consent.

Exclusion Criteria:

  • Hospitalization within 4 weeks of baseline visit
  • History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
  • Current or anticipated dialysis during study
  • In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
  • Drug or alcohol abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01598740
CTST-25
No
Sorbent Therapeutics
Sorbent Therapeutics
Not Provided
Study Chair: Howard Dittrich, MD Sorbent Therapeutics, Study Sponsor
Principal Investigator: Joel Neutel, MD Orange County Research Center
Sorbent Therapeutics
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP