Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

March 12, 2013 updated by: Sorbent Therapeutics

A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease

The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

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

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 III or IV
  • Hospitalization for heart failure decompensation associated with fluid overload within the last six months
  • Chronic kidney disease
  • Must be able to understand study procedures and willing and able to provide written informed consent

Exclusion Criteria:

  • No hospitalization within 4 weeks of Baseline Visit
  • In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe
  • History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
  • Current dialysis patient, or anticipated need for dialysis during study participation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CLP
Investigational drug: 15 g CLP per day given as capsules
Drug: CLP
Oral administration
Placebo Comparator: Placebo
Placebo, capsules
Drug: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Potassium
Time Frame: Baseline and 8 weeks
Change in serum potassium from baseline to Week 8.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss at Week 1
Time Frame: Baseline and 1 week
Baseline and 1 week
Weight Loss at Week 2
Time Frame: Baseline and 2 weeks
Baseline and 2 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
Time Frame: 4 weeks
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
4 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
Time Frame: 8 weeks
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.
8 weeks
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
6MWT Distance at Week 8
Time Frame: Baseline and 8 weeks
Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.
Baseline and 8 weeks

Collaborators and Investigators

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

Sponsor

Sorbent Therapeutics

Collaborators

Pharmaterra

Investigators

  • Study Chair: Detlef Albrecht, MD, Sorbent Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 12, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTST-21

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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Locations

3
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