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

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ClinicalTrials.gov Identifier: NCT01598740
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : May 8, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Sorbent Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: CLP Drug: Spironolactone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CLP with spironolactone Drug: CLP
Oral administration
Drug: Spironolactone
oral administration
Experimental: CLP without spironolactone Drug: CLP
Oral administration



Primary Outcome Measures :
  1. 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) ]
    Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)


Secondary Outcome Measures :
  1. Change in Fecal Weight [ Time Frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) ]
    Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598740


Locations
United States, California
Orange Country Research Center
Tustin, California, United States, 92780
Sponsors and Collaborators
Sorbent Therapeutics
Investigators
Study Chair: Howard Dittrich, MD Sorbent Therapeutics, Study Sponsor
Principal Investigator: Joel Neutel, MD Orange County Research Center

Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01598740     History of Changes
Other Study ID Numbers: CTST-25
First Posted: May 15, 2012    Key Record Dates
Results First Posted: May 8, 2013
Last Update Posted: July 19, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents