Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.

Sponsor:

Collaborator:

Pharmaterra

Information provided by (Responsible Party):

Sorbent Therapeutics

ClinicalTrials.gov Identifier:

NCT01265524

First received: December 20, 2010

Last updated: March 12, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2010

Last Updated Date

March 12, 2013

Start Date ^ICMJE

April 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]

Change in serum potassium from baseline to Week 8.

Original Primary Outcome Measures ^ICMJE

Change in serum potassium [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01265524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Weight Loss at Week 1 [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
Weight Loss at Week 2 [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
6MWT Distance at Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Signs and symptoms of fluid overload [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Drug: CLP
Oral administration
Drug: Placebo
Oral administration

Study Arm (s)

Active Comparator: CLP
Investigational drug: 15 g CLP per day given as capsules

Intervention: Drug: CLP
Placebo Comparator: Placebo
Placebo, capsules

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

113

Completion Date

Not Provided

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Armenia, Georgia, Moldova, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01265524

Other Study ID Numbers ^ICMJE

CTST-21

Has Data Monitoring Committee

Responsible Party

Sorbent Therapeutics

Study Sponsor ^ICMJE

Sorbent Therapeutics

Collaborators ^ICMJE

Pharmaterra

Investigators ^ICMJE

Study Chair:

Detlef Albrecht, MD

Sorbent Therapeutics

Information Provided By

Sorbent Therapeutics

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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