Back to resultsEvaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CLP
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CLP
Placebo
Arm Description
Investigational drug: 15 g CLP per day given as capsules
Placebo, capsules
Outcomes
Primary Outcome Measures
Change in Serum Potassium
Change in serum potassium from baseline to Week 8.
Secondary Outcome Measures
Weight Loss at Week 1
Weight Loss at Week 2
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
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
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
6MWT Distance at Week 8
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.
Full Information
NCT ID
NCT01265524
First Posted
December 20, 2010
Last Updated
March 12, 2013
Sponsor
Sorbent Therapeutics
Collaborators
Pharmaterra
1. Study Identification
Unique Protocol Identification Number
NCT01265524
Brief Title
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Official Title
A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorbent Therapeutics
Collaborators
Pharmaterra
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLP
Arm Type
Active Comparator
Arm Description
Investigational drug: 15 g CLP per day given as capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, capsules
Intervention Type
Drug
Intervention Name(s)
CLP
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Change in Serum Potassium
Description
Change in serum potassium from baseline to Week 8.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Weight Loss at Week 1
Time Frame
Baseline and 1 week
Title
Weight Loss at Week 2
Time Frame
Baseline and 2 weeks
Title
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
Description
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
Time Frame
4 weeks
Title
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
Description
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.
Time Frame
8 weeks
Title
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
Time Frame
Baseline and 8 weeks
Title
6MWT Distance at Week 8
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Detlef Albrecht, MD
Organizational Affiliation
Sorbent Therapeutics
Official's Role
Study Chair
Facility Information:
City
Yerevan
Country
Armenia
City
Tbilisi
Country
Georgia
City
Chisinau
Country
Moldova, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22613585
Citation
Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease. Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.
Results Reference
result
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Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
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