Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

NCT01265524 | Completed Phase 2 Results

• 1 other identifier: CTST-21
• Study Type: interventional
• Target: 113
• Locations: 3 countries
• Sites: 3

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Serum Potassium

  Change in serum potassium from baseline to Week 8.

  Baseline and 8 weeks

Secondary Outcomes (6)

• Weight Loss at Week 1

  Baseline and 1 week

• Weight Loss at Week 2

  Baseline and 2 weeks

• Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4

  4 weeks

• Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8

  8 weeks

• Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8

  Baseline and 8 weeks

Study Arms (2)

CLP

ACTIVE COMPARATOR

Investigational drug: 15 g CLP per day given as capsules

Drug: CLP

Placebo

PLACEBO COMPARATOR

Placebo, capsules

Drug: Placebo

Interventions

CLP DRUG

Oral administration

CLP

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorbent Therapeutics: lead
• Pharmaterra: collaborator

Study Sites (3)

Unknown Facility

Yerevan, Armenia

Location

Unknown Facility

Tbilisi, Georgia

Location

Unknown Facility

Chisinau, Moldova

Location

Related 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 polyelectrolyte in heart failure patients with chronic kidney disease. Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.

  PMID: 22613585 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Howard Dittrich, MD FACC
• Organization: Sorbent Therapeutics

hdittrich@sorbent.com

858-405-1429

Study Officials

• Detlef Albrecht, MD

  Sorbent Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 23, 2010
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Last Updated: March 13, 2013
• Results First Posted: March 13, 2013

Record last verified: 2013-03

Locations

AR (1); MO (1); GE (1)