Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
This study has been completed.
Information provided by (Responsible Party):
First received: December 20, 2010
Last updated: March 12, 2013
Last verified: March 2013
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease|
Resource links provided by NLM:
MedlinePlus related topics: Breathing Problems Chronic Kidney Disease Heart Failure Potassium Weight ControlU.S. FDA Resources
Further study details as provided by Sorbent Therapeutics:
Primary Outcome Measures:
- Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]Change in serum potassium from baseline to Week 8.
Secondary Outcome Measures:
- 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.
|Study Start Date:||April 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: CLP
Investigational drug: 15 g CLP per day given as capsules
Placebo Comparator: Placebo
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265524
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
Sponsors and Collaborators
|Study Chair:||Detlef Albrecht, MD||Sorbent Therapeutics|