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
  Purpose

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 Intervention Phase
Heart Failure
Drug: CLP
Drug: Placebo
Phase 2

Study Type: Interventional
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:


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.


Enrollment: 113
Study Start Date: April 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01265524     History of Changes
Other Study ID Numbers: CTST-21
Study First Received: December 20, 2010
Results First Received: January 3, 2013
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration
Armenia: Ministry of Health
Georgia: Ministry of Health
Moldova: Ministry of Health

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

ClinicalTrials.gov processed this record on April 14, 2014