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The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLP with spironolactone | Experimental |
| |
| CLP without spironolactone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLP | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fecal Sodium Content | Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average) | baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fecal Weight | Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average) | baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Dittrich, MD | Sorbent Therapeutics, Study Sponsor | Study Chair |
| Joel Neutel, MD | Orange County Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange Country Research Center | Tustin | California | 92780 | United States |
Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.
The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days) | Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2. |
| FG001 | CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days) | Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CLP + Spiro/CLP | Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2. |
| BG001 | CLP/CLP + Spiro |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 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 Fecal Sodium Content | Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average) | Posted | Mean | Standard Deviation | mg | baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) |
|
|
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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 | Treatment Group: CLP Alone | oral administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Dittrich, MD | Sorbent Therapeutics, Inc. | 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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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Spironolactone |
| Drug |
oral administration |
|
| NOT COMPLETED |
|
Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Diet | Number | participants |
|
| Participants |
|
|
|
| Secondary | Change in Fecal Weight | Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average) | Posted | Mean | Standard Deviation | grams | baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) |
|
|
|
|
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Treatment Group: CLP + Spironolactone | CLP: oral administration Spironolactone: oral administration | 0 | 18 | 8 | 18 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotenstion | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |