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| Name | Class |
|---|---|
| Pharmaterra | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLP | Active Comparator | Investigational drug: 15 g CLP per day given as capsules |
|
| Placebo | Placebo Comparator | Placebo, capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLP | Drug | Oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Potassium | Change in serum potassium from baseline to Week 8. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Detlef Albrecht, MD | Sorbent Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yerevan | Armenia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22613585 | Result | 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. |
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Although 113 subjects were randomized, 2 subjects did not receive study drug and were removed from the analysis as pre- specified in the SAP.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Drug: CLP | Investigational drug: 15 g CLP per day given as capsules |
| FG001 | Placebo | Placebo: capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Drug: CLP | Investigational drug: 15g CLP per day given as capsules |
| BG001 | Placebo | Placebo: capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Potassium | Change in serum potassium from baseline to Week 8. | 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. | Posted | Mean | Standard Deviation | mg/dl | Baseline and 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Drug: CLP | Investigational drug: 15g CLP per day given as capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Dittrich, MD FACC | Sorbent Therapeutics | 858-405-1429 | hdittrich@sorbent.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
Oral administration |
|
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4. |
| 4 weeks |
| 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 |
| Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 | Baseline and 8 weeks |
| 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 |
| Tbilisi |
| Georgia |
| Chisinau | Moldova |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| eGFR | Mean | Standard Deviation | ml/min/1.73m3 |
|
| New York Heart Association (NYHA) Functional Class | 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 | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Weight Loss at Week 1 | 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. | Posted | Mean | Standard Deviation | kg | Baseline and 1 week |
|
|
|
|
| Secondary | Weight Loss at Week 2 | 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. | Posted | Mean | Standard Deviation | kg | Baseline and 2 weeks |
|
|
|
| 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. | Posted | Number | participants | 4 weeks |
|
|
|
| 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. | Posted | Number | participants | 8 weeks |
|
|
|
| Secondary | Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8 | 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. | Posted | Number | participants | Baseline and 8 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | m | Baseline and 8 weeks |
|
|
|
|
| 4 |
| 59 |
| 21 |
| 59 |
| EG001 | Placebo | Placebo: capsules | 1 | 52 | 13 | 52 |
| Cardiac failure acute | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Sudden death | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
A standard confidentiality agreement is in place.