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Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01265524
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Pharmaterra
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: CLP Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2011
Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CLP
Investigational drug: 15 g CLP per day given as capsules
Drug: CLP
Oral administration
Placebo Comparator: Placebo
Placebo, capsules
Drug: Placebo
Oral administration



Primary Outcome Measures :
  1. Change in Serum Potassium [ Time Frame: Baseline and 8 weeks ]
    Change in serum potassium from baseline to Week 8.


Secondary Outcome Measures :
  1. Weight Loss at Week 1 [ Time Frame: Baseline and 1 week ]
  2. Weight Loss at Week 2 [ Time Frame: Baseline and 2 weeks ]
  3. 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.

  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.

  5. Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 [ Time Frame: Baseline and 8 weeks ]
  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265524


Locations
Armenia
Yerevan, Armenia
Georgia
Tbilisi, Georgia
Moldova, Republic of
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Sorbent Therapeutics
Pharmaterra
Investigators
Study Chair: Detlef Albrecht, MD Sorbent Therapeutics

Publications:
Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01265524     History of Changes
Other Study ID Numbers: CTST-21
First Posted: December 23, 2010    Key Record Dates
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency