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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 heart-failure
Started Jun 2012
Shorter than P25 for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
May 8, 2013
CompletedJuly 19, 2013
July 1, 2013
3 months
May 11, 2012
March 22, 2013
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Fecal Sodium Content
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Secondary Outcomes (1)
Change in Fecal Weight
baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)
Study Arms (2)
CLP with spironolactone
EXPERIMENTALCLP without spironolactone
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orange Country Research Center
Tustin, California, 92780, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard Dittrich, MD
- Organization
- Sorbent Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Howard Dittrich, MD
Sorbent Therapeutics, Study Sponsor
- PRINCIPAL INVESTIGATOR
Joel Neutel, MD
Orange County Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 15, 2012
Study Start
June 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 19, 2013
Results First Posted
May 8, 2013
Record last verified: 2013-07