Trial Outcomes & Findings for Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease (NCT NCT01265524)

NCT ID: NCT01265524

Last Updated: 2013-03-13

Results Overview

Change in serum potassium from baseline to Week 8.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 113 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2013-03-13

Participant Flow

Although 113 subjects were randomized, 2 subjects did not receive study drug and were removed from the analysis as pre- specified in the SAP.

Participant milestones

Measure	Investigational Drug: CLP Investigational drug: 15 g CLP per day given as capsules	Placebo Placebo: capsules
Overall Study STARTED	59	52
Overall Study COMPLETED	41	46
Overall Study NOT COMPLETED	18	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Investigational Drug: CLP n=59 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=52 Participants Placebo: capsules	Total n=111 Participants Total of all reporting groups
Age, Customized	68 years STANDARD_DEVIATION 8 • n=93 Participants	70 years STANDARD_DEVIATION 10 • n=4 Participants	69 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	23 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	42 Participants n=93 Participants	29 Participants n=4 Participants	71 Participants n=27 Participants
Weight	75.3 kg STANDARD_DEVIATION 13.6 • n=93 Participants	75.1 kg STANDARD_DEVIATION 16.2 • n=4 Participants	75.2 kg STANDARD_DEVIATION 14.9 • n=27 Participants
eGFR	45.0 ml/min/1.73m3 STANDARD_DEVIATION 14.2 • n=93 Participants	44.9 ml/min/1.73m3 STANDARD_DEVIATION 17.3 • n=4 Participants	45 ml/min/1.73m3 STANDARD_DEVIATION 15.8 • n=27 Participants
New York Heart Association (NYHA) Functional Class II	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants
New York Heart Association (NYHA) Functional Class III	52 participants n=93 Participants	45 participants n=4 Participants	97 participants n=27 Participants
New York Heart Association (NYHA) Functional Class IV	7 participants n=93 Participants	5 participants n=4 Participants	12 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Change in serum potassium from baseline to Week 8.

Outcome measures

Measure	Investigational Drug: CLP n=41 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=46 Participants Placebo: capsules
Change in Serum Potassium	0.15 mg/dl Standard Deviation 0.348	0.05 mg/dl Standard Deviation 0.345

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Investigational Drug: CLP n=56 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=52 Participants Placebo: capsules
Weight Loss at Week 1	-0.71 kg Standard Deviation 1.5	0.11 kg Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Investigational Drug: CLP n=52 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=51 Participants Placebo: capsules
Weight Loss at Week 2	-0.83 kg Standard Deviation 1.8	0.29 kg Standard Deviation 2.3

SECONDARY outcome

Timeframe: 4 weeks

The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.

Outcome measures

Measure	Investigational Drug: CLP n=47 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=48 Participants Placebo: capsules
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4	10 participants	14 participants

SECONDARY outcome

Timeframe: 8 weeks

The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.

Outcome measures

Measure	Investigational Drug: CLP n=41 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=46 Participants Placebo: capsules
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8	5 participants	12 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Investigational Drug: CLP n=41 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=46 Participants Placebo: capsules
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8	20 participants	8 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Investigational Drug: CLP n=41 Participants Investigational drug: 15g CLP per day given as capsules	Placebo n=46 Participants Placebo: capsules
6MWT Distance at Week 8	39.3 m Standard Deviation 53.39	19.7 m Standard Deviation 39.17

Adverse Events

Investigational Drug: CLP

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Investigational Drug: CLP n=59 participants at risk Investigational drug: 15g CLP per day given as capsules	Placebo n=52 participants at risk Placebo: capsules
Cardiac disorders Cardiac failure	1.7% 1/59 • Number of events 1	0.00% 0/52
Cardiac disorders Cardiac failure acute	1.7% 1/59 • Number of events 1	1.9% 1/52 • Number of events 1
Cardiac disorders Sudden death	1.7% 1/59 • Number of events 1	0.00% 0/52
Cardiac disorders Renal failure	1.7% 1/59 • Number of events 1	0.00% 0/52

Other adverse events

Measure	Investigational Drug: CLP n=59 participants at risk Investigational drug: 15g CLP per day given as capsules	Placebo n=52 participants at risk Placebo: capsules
Gastrointestinal disorders Abdominal discomfort	11.9% 7/59	3.8% 2/52
Gastrointestinal disorders Abdominal distention	5.1% 3/59	1.9% 1/52
Gastrointestinal disorders Nausea	5.1% 3/59	0.00% 0/52
Gastrointestinal disorders Vomiting	1.7% 1/59	5.8% 3/52
General disorders Oedema peripheral	6.8% 4/59	1.9% 1/52
Metabolism and nutrition disorders Decreased appetite	3.4% 2/59	0.00% 0/52
Metabolism and nutrition disorders Hyperkalaemia	3.4% 2/59	3.8% 2/52
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/59	3.8% 2/52
Vascular disorders Hypertension	1.7% 1/59	3.8% 2/52

Additional Information

Howard Dittrich, MD FACC

Sorbent Therapeutics

Phone: 858-405-1429

Email: hdittrich@sorbent.com

Results disclosure agreements

• Principal investigator is a sponsor employee A standard confidentiality agreement is in place.
• Publication restrictions are in place

Restriction type: OTHER