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

July 12, 2013 updated by: Sorbent Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange Country Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLP with spironolactone
Drug: CLP
Oral administration
Drug: Spironolactone
oral administration
Experimental: CLP without spironolactone
Drug: CLP
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorbent Therapeutics

Investigators

  • Study Chair: Howard Dittrich, MD, Sorbent Therapeutics, Study Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 12, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTST-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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