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Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01265524
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Pharmaterra
Information provided by (Responsible Party):
Sorbent Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Heart Failure
Interventions Drug: CLP
Drug: Placebo
Enrollment 113
Recruitment Details  
Pre-assignment Details Although 113 subjects were randomized, 2 subjects did not receive study drug and were removed from the analysis as pre- specified in the SAP.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description Investigational drug: 15 g CLP per day given as capsules Placebo: capsules
Period Title: Overall Study
Started 59 52
Completed 41 46
Not Completed 18 6
Arm/Group Title Investigational Drug: CLP Placebo Total
Hide Arm/Group Description Investigational drug: 15g CLP per day given as capsules Placebo: capsules Total of all reporting groups
Overall Number of Baseline Participants 59 52 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 52 participants 111 participants
68  (8) 70  (10) 69  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 52 participants 111 participants
Female
17
  28.8%
23
  44.2%
40
  36.0%
Male
42
  71.2%
29
  55.8%
71
  64.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 59 participants 52 participants 111 participants
75.3  (13.6) 75.1  (16.2) 75.2  (14.9)
eGFR  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m3
Number Analyzed 59 participants 52 participants 111 participants
45.0  (14.2) 44.9  (17.3) 45  (15.8)
New York Heart Association (NYHA) Functional Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 52 participants 111 participants
II 0 2 2
III 52 45 97
IV 7 5 12
[1]
Measure Description: NYHA Functional Classes are I, II, III, and IV A brief summary of the classes is included below. Class I: patients with cardiac disease but without resulting limitations of physical activity Class II: patients with cardiac disease with slight limitations to physical activity Class III: patients with cardiac disease with marked limitations of physical activity Class IV: patients with cardiac disease resulting in an inability to carry out physical activity without discomfort
1.Primary Outcome
Title Change in Serum Potassium
Hide Description Change in serum potassium from baseline to Week 8.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 41 46
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.15  (0.348) 0.05  (0.345)
2.Secondary Outcome
Title Weight Loss at Week 1
Hide Description [Not Specified]
Time Frame Baseline and 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 56 52
Mean (Standard Deviation)
Unit of Measure: kg
-0.71  (1.5) 0.11  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Drug: CLP, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Statistical Test of Hypothesis P-Value 0.014
Comments Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.
Method ANCOVA
Comments Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.
3.Secondary Outcome
Title Weight Loss at Week 2
Hide Description [Not Specified]
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: kg
-0.83  (1.8) 0.29  (2.3)
4.Secondary Outcome
Title Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
Hide Description The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 47 48
Measure Type: Number
Unit of Measure: participants
10 14
5.Secondary Outcome
Title Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
Hide Description The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 41 46
Measure Type: Number
Unit of Measure: participants
5 12
6.Secondary Outcome
Title Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 41 46
Measure Type: Number
Unit of Measure: participants
20 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Drug: CLP, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Statistical Test of Hypothesis P-Value 0.0002
Comments Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.
Method ANCOVA
Comments Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.
7.Secondary Outcome
Title 6MWT Distance at Week 8
Hide Description 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.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description:
Investigational drug: 15g CLP per day given as capsules
Placebo: capsules
Overall Number of Participants Analyzed 41 46
Mean (Standard Deviation)
Unit of Measure: m
39.3  (53.39) 19.7  (39.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Drug: CLP, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.
Statistical Test of Hypothesis P-Value 0.072
Comments Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.
Method ANCOVA
Comments Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational Drug: CLP Placebo
Hide Arm/Group Description Investigational drug: 15g CLP per day given as capsules Placebo: capsules
All-Cause Mortality
Investigational Drug: CLP Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Investigational Drug: CLP Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/59 (6.78%)      1/52 (1.92%)    
Cardiac disorders     
Cardiac failure  1  1/59 (1.69%)  1 0/52 (0.00%)  0
Cardiac failure acute  1  1/59 (1.69%)  1 1/52 (1.92%)  1
Sudden death  1  1/59 (1.69%)  1 0/52 (0.00%)  0
Renal failure  1  1/59 (1.69%)  1 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Investigational Drug: CLP Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/59 (35.59%)      13/52 (25.00%)    
Gastrointestinal disorders     
Abdominal discomfort  1  7/59 (11.86%)  2/52 (3.85%) 
Abdominal distention  1  3/59 (5.08%)  1/52 (1.92%) 
Nausea  1  3/59 (5.08%)  0/52 (0.00%) 
Vomiting  1  1/59 (1.69%)  3/52 (5.77%) 
General disorders     
Oedema peripheral  1  4/59 (6.78%)  1/52 (1.92%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/59 (3.39%)  0/52 (0.00%) 
Hyperkalaemia  1  2/59 (3.39%)  2/52 (3.85%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/59 (0.00%)  2/52 (3.85%) 
Vascular disorders     
Hypertension  1  1/59 (1.69%)  2/52 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A standard confidentiality agreement is in place.
Results Point of Contact
Name/Title: Howard Dittrich, MD FACC
Organization: Sorbent Therapeutics
Phone: 858-405-1429
Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01265524     History of Changes
Other Study ID Numbers: CTST-21
First Submitted: December 20, 2010
First Posted: December 23, 2010
Results First Submitted: January 3, 2013
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013