Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Sorbent Therapeutics

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: CLP

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01265524

CTST-21

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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113 participants in 2 patient groups, including a placebo group

CLP

Active Comparator group

Description:

Investigational drug: 15 g CLP per day given as capsules

Treatment:

Drug: CLP

Placebo

Placebo Comparator group

Description:

Placebo, capsules

Treatment:

Drug: Placebo