Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: CLP; Drug: Placebo

• Registration Number: NCT01265524
• Lead Sponsor: Sorbent Therapeutics

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 available

Study Timeline

• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-23
• Study Start: 2011-04
• Primary Completion: 2011-11
• Results First Submitted: 2013-01-03
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-12
• Last Update Submitted: 2013-03-12
• Results First Posted: 2013-03-13
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLP	CLP	Investigational drug: 15 g CLP per day given as capsules
Placebo	Placebo	Placebo, capsules

Primary Outcome Measures

Name	Time	Method
Change in Serum Potassium	Baseline and 8 weeks	Change in serum potassium from baseline to Week 8.

Secondary Outcome Measures

Name	Time	Method
Weight Loss at Week 1	Baseline and 1 week
Weight Loss at Week 2	Baseline and 2 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4	4 weeks	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	8 weeks	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	Baseline and 8 weeks
6MWT Distance at Week 8	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.