Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
|ClinicalTrials.gov Identifier: NCT01265524|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: CLP Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2011|
Active Comparator: CLP
Investigational drug: 15 g CLP per day given as capsules
Placebo Comparator: Placebo
- Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ]Change in serum potassium from baseline to Week 8.
- Weight Loss at Week 1 [ Time Frame: Baseline and 1 week ]
- Weight Loss at Week 2 [ Time Frame: 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.
- 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.
- Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265524
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
|Study Chair:||Detlef Albrecht, MD||Sorbent Therapeutics|