Status:
COMPLETED
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Lead Sponsor:
Sorbent Therapeutics
Collaborating Sponsors:
Pharmaterra
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01265524
Start Date
April 1 2011
Last Update
March 13 2013
Active Locations (3)
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1
Yerevan, Armenia
2
Tbilisi, Georgia
3
Chisinau, Moldova