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Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265524
First Posted: December 23, 2010
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pharmaterra
Information provided by (Responsible Party):
Sorbent Therapeutics
December 20, 2010
December 23, 2010
January 3, 2013
March 13, 2013
March 13, 2013
April 2011
November 2011   (Final data collection date for primary outcome measure)
Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ]
Change in serum potassium from baseline to Week 8.
Change in Serum Potassium [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01265524 on ClinicalTrials.gov Archive Site
  • 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.
Signs and symptoms of fluid overload [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Heart Failure
  • Drug: CLP
    Oral administration
  • Drug: Placebo
    Oral administration
  • Active Comparator: CLP
    Investigational drug: 15 g CLP per day given as capsules
    Intervention: Drug: CLP
  • Placebo Comparator: Placebo
    Placebo, capsules
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
Not Provided
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Armenia,   Georgia,   Moldova, Republic of
 
 
NCT01265524
CTST-21
No
Not Provided
Not Provided
Sorbent Therapeutics
Sorbent Therapeutics
Pharmaterra
Study Chair: Detlef Albrecht, MD Sorbent Therapeutics
Sorbent Therapeutics
March 2013

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