Phase 2 N=111 Randomized Quadruple-blind Prevention

Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01265524 ↗

Enrolled (actual)

111

Serious AEs

4.5%

Results posted

Mar 2013

Primary outcome: Primary: Change in Serum Potassium — 0.15; 0.05 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CLP (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sorbent Therapeutics
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Serum Potassium	0.15; 0.05	—
SECONDARY Weight Loss at Week 1	-0.71; 0.11	0.014 sig
SECONDARY Weight Loss at Week 2	-0.83; 0.29	—
SECONDARY Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4	10; 14	—
SECONDARY Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8	5; 12	—
SECONDARY Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8	20; 8	0.0002 sig
SECONDARY 6MWT Distance at Week 8	39.3; 19.7	0.072

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01265524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.