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Completed

NCT Number: NCT01265524

Evaluation of CLP 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yerevan, Armenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLP

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Change in Serum Potassium

    Time frame: Baseline and 8 weeks

    Change in serum potassium from baseline to Week 8.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sorbent Therapeutics

Industry

Collaborators

  • Pharmaterra

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease

Important dates

Study start
2011
Primary completion
2011
First posted
Dec 23, 2010
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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