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

Information source: Sorbent Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: CLP (Drug); Spironolactone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sorbent Therapeutics

Official(s) and/or principal investigator(s):
Howard Dittrich, MD, Study Chair, Affiliation: Sorbent Therapeutics, Study Sponsor
Joel Neutel, MD, Principal Investigator, Affiliation: Orange County Research Center

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Fecal Sodium Content

Secondary outcome: Change in Fecal Weight

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Orange Country Research Center, Tustin, California 92780, United States
Additional Information

Starting date: June 2012
Last updated: July 12, 2013

Page last updated: August 23, 2015

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