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To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC-Standard of care | No Intervention | standard of care, nontreatment | |
| spironolactone | Experimental | spironolactone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | spironolactone 25 mg up to 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular Filtration Rate (GFR) | The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W. Russo, MD, MPH | Charolinas Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHS | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Russo MW, Krista Bossi, Gale Groseclose, Levi DM, Lon Eskind, Bennett Noell, Anderson WE, Zamor PJ, Vincent Casingal. Estimates of Glomerular filtration rate in liver transplant recipients are not accurate: A role for 24 hour urine creatinine clearance. Archives of Transplantation 2018:2:1-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC-Standard of Care | standard of care, nontreatment |
| FG001 | Spironolactone | spironolactone Spironolactone: spironolactone 25 mg up to 50 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SOC-Standard of Care | standard of care, nontreatment |
| BG001 | Spironolactone | spironolactone Spironolactone: spironolactone 25 mg up to 50 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Glomerular Filtration Rate (GFR) | The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan. | liver transplant recipients | Posted | Mean | Inter-Quartile Range | ml/min/1.73m^2 | 18 months |
|
|
18 months
adverse events were collected according to clinical trials. gov defintions or by clinical descrption
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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 | SOC-Standard of Care | standard of care, nontreatment | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA (10.0) | Systematic Assessment | 2 patients in SOC arm and 2 patients in treatment arm were hospitalized for Fever. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated serum potassium | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Russo, | Atrium Health | 704-355-6649 | mark.russo@atriumhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2016 | Aug 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glomerular Filtration Rate | Mean | Inter-Quartile Range | mL/min//1.73m^2 |
|
| Participants |
|
|
|
| 22 |
| 2 |
| 22 |
| 1 |
| 22 |
| EG001 | Spironolactone | spironolactone Spironolactone: spironolactone 25 mg up to 50 mg | 1 | 8 | 2 | 8 | 3 | 8 |
|
| cardiopulmonary arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Subject expired from cardiopulmonary arrest and liver failure |
|
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |