Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265524
• Other study ID #: CTST-21
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2010
• Last updated: March 12, 2013
• Start date: April 2011

Study information

• Verified date: March 2013
• Source: Sorbent Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArmenia: Ministry of HealthGeorgia: Ministry of HealthMoldova: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• CLP
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sorbent Therapeutics	Pharmaterra

Countries where clinical trial is conducted

Armenia,  Georgia,  Moldova, Republic of, 

References & Publications (1)

Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Potassium	Change in serum potassium from baseline to Week 8.	Baseline and 8 weeks	Yes
Secondary	Weight Loss at Week 1		Baseline and 1 week	No
Secondary	Weight Loss at Week 2		Baseline and 2 weeks	No
Secondary	Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4	The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.	4 weeks	No
Secondary	Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8	The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.	8 weeks	No
Secondary	Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8		Baseline and 8 weeks	Yes
Secondary	6MWT Distance at Week 8	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.	Baseline and 8 weeks	No