Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Pharmaterra
Information provided by (Responsible Party):
Sorbent Therapeutics
ClinicalTrials.gov Identifier:
NCT01265524
First received: December 20, 2010
Last updated: March 12, 2013
Last verified: March 2013

December 20, 2010
March 12, 2013
April 2011
November 2011   (final data collection date for primary outcome measure)
Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
Change in serum potassium from baseline to Week 8.
Change in serum potassium [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01265524 on ClinicalTrials.gov Archive Site
  • 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.
Signs and symptoms of fluid overload [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Armenia,   Georgia,   Moldova, Republic of
 
NCT01265524
CTST-21
No
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