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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: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Heart Failure
 Drug: CLP
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sorbent Therapeutics:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 18
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLP with spironolactone Drug: CLP
Oral administration
Experimental: CLP without spironolactone Drug: CLP
Oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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: March 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Spironolactone
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013