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Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01265524
Enrollment
113
Registered
2010-12-23
Start date
2011-04-30
Completion date
Unknown
Last updated
2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DRUGCLP

Oral administration

DRUGPlacebo

Oral administration

Sponsors

Pharmaterra
CollaboratorUNKNOWN
Sorbent Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Serum PotassiumBaseline and 8 weeksChange in serum potassium from baseline to Week 8.

Secondary

MeasureTime frameDescription
Weight Loss at Week 2Baseline and 2 weeks—
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 44 weeksThe frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
Weight Loss at Week 1Baseline and 1 week—
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8Baseline and 8 weeks—
6MWT Distance at Week 8Baseline and 8 weeksIncrease 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.
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 88 weeksThe frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.

Countries

Armenia, Georgia, Moldova

Participant flow

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.

Participants by arm

ArmCount
Investigational Drug: CLP
Investigational drug: 15g CLP per day given as capsules
59
Placebo
Placebo: capsules
52
Total111

Baseline characteristics

CharacteristicInvestigational Drug: CLPPlaceboTotal
Age, Customized68 years
STANDARD_DEVIATION 8
70 years
STANDARD_DEVIATION 10
69 years
STANDARD_DEVIATION 9
eGFR45.0 ml/min/1.73m3
STANDARD_DEVIATION 14.2
44.9 ml/min/1.73m3
STANDARD_DEVIATION 17.3
45 ml/min/1.73m3
STANDARD_DEVIATION 15.8
New York Heart Association (NYHA) Functional Class
II
0 participants2 participants2 participants
New York Heart Association (NYHA) Functional Class
III
52 participants45 participants97 participants
New York Heart Association (NYHA) Functional Class
IV
7 participants5 participants12 participants
Sex: Female, Male
Female
17 Participants23 Participants40 Participants
Sex: Female, Male
Male
42 Participants29 Participants71 Participants
Weight75.3 kg
STANDARD_DEVIATION 13.6
75.1 kg
STANDARD_DEVIATION 16.2
75.2 kg
STANDARD_DEVIATION 14.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
21 / 5913 / 52
serious
Total, serious adverse events
4 / 591 / 52

Outcome results

Primary

Change in Serum Potassium

Change in serum potassium from baseline to Week 8.

Time frame: Baseline and 8 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Investigational Drug: CLPChange in Serum Potassium0.15 mg/dlStandard Deviation 0.348
PlaceboChange in Serum Potassium0.05 mg/dlStandard Deviation 0.345
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.

Time frame: Baseline and 8 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Investigational Drug: CLP6MWT Distance at Week 839.3 mStandard Deviation 53.39
Placebo6MWT Distance at Week 819.7 mStandard Deviation 39.17
p-value: 0.072ANCOVA
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.

Time frame: 4 weeks

ArmMeasureValue (NUMBER)
Investigational Drug: CLPFrequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 410 participants
PlaceboFrequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 414 participants
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.

Time frame: 8 weeks

ArmMeasureValue (NUMBER)
Investigational Drug: CLPFrequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 85 participants
PlaceboFrequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 812 participants
Secondary

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

Time frame: Baseline and 8 weeks

Population: 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.

ArmMeasureValue (NUMBER)
Investigational Drug: CLPNumber of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 820 participants
PlaceboNumber of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 88 participants
p-value: 0.0002ANCOVA
Secondary

Weight Loss at Week 1

Time frame: Baseline and 1 week

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Investigational Drug: CLPWeight Loss at Week 1-0.71 kgStandard Deviation 1.5
PlaceboWeight Loss at Week 10.11 kgStandard Deviation 2
p-value: 0.014ANCOVA
Secondary

Weight Loss at Week 2

Time frame: Baseline and 2 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Investigational Drug: CLPWeight Loss at Week 2-0.83 kgStandard Deviation 1.8
PlaceboWeight Loss at Week 20.29 kgStandard Deviation 2.3

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026