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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion Arm | Other | Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus Extended Release Capsule | Drug | goal trough 5 - 12ng/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized Trough | Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® | Baseline to 3 months post-conversion |
| Measure | Description | Time Frame |
|---|---|---|
| Total Daily Dose | Difference in Total Daily Dose necessary for steady state therapeutic goal | Baseline to 3 months post conversion |
| Weight-Based Dose Requirement | Weight-based dose requirements to reach therapeutic goal pre- and post-conversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Fleming, PharmD | Medicual U of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
The data will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conversion Arm | Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL Mycophenolate mofetil: ≥500mg twice a day Prednisone: goal dose 5mg daily Mycophenolate Sodium: ≥360mg twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conversion Arm | Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL Mycophenolate mofetil: ≥500mg twice a day Prednisone: goal dose 5mg daily Mycophenolate Sodium: ≥360mg twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Dose-normalized Trough | Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® | Posted | Median | Inter-Quartile Range | ng/dL | Baseline to 3 months post-conversion |
|
|
Adverse events were collected over 3 months
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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 | Conversion Arm | Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily Tacrolimus Extended Release Capsule: goal trough 5 - 12ng/mL Mycophenolate mofetil: ≥500mg twice a day Prednisone: goal dose 5mg daily Mycophenolate Sodium: ≥360mg twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic myeloid Leukemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Schaffner | Medical University of South Carolina | 843-792-7558 | schaffne@musc.edu |
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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 | Dec 12, 2017 | Aug 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| D000305 | Adrenal Cortex Hormones |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 |
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| Mycophenolate mofetil | Drug | ≥500mg twice a day |
|
|
| Prednisone | Drug | goal dose 5mg daily |
|
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| Mycophenolate Sodium | Drug | ≥360mg twice a day |
|
|
| Baseline to 3 months post conversion |
| Number of Days to Reach Therapeutic Trough Goal | Days to reach therapeutic goal after conversion | Baseline to 3 months post conversion |
| Dose Modifications | Number of dose modifications from baseline to 3 months post-conversion. | Baseline to 3 months post conversion |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Days Since Transplant | Median | Inter-Quartile Range | days |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Calculated Panel Reactive Antibodies (cPRA) | Calculated Panel Reactive Antibodies (cPRA) is used to determine the likelihood that a transplant recipient and donor would be incompatible. The scale goes from 0% to 100 %. A higher % means there is a higher likelihood that the recipient and donor are incompatible. | Median | Inter-Quartile Range | percent |
|
| Number of participants on Hemodialysis Prior to Transplant | Count of Participants | Participants |
|
| Cold Ischemic Time | The Cold Ischemic Time is the amount of time that the donor kidney has blood supply cut off. The time starts when blood supply is cut off from the donor kidney and put on ice, and ends when the kidney is taken out of ice in preparation for transplant to the recipient. | Median | Inter-Quartile Range | hours |
|
| Warm Ischemic Time | The warm ischemia time is the amount of time, from when the donor kidney is taken out of ice until the kidney has blood flow restored in the transplant recipient. | Mean | Standard Deviation | minutes |
|
| Participants |
|
|
| Secondary | Total Daily Dose | Difference in Total Daily Dose necessary for steady state therapeutic goal | Posted | Median | Inter-Quartile Range | mg | Baseline to 3 months post conversion |
|
|
|
| Secondary | Weight-Based Dose Requirement | Weight-based dose requirements to reach therapeutic goal pre- and post-conversion | Posted | Median | Inter-Quartile Range | mg/kg | Baseline to 3 months post conversion |
|
|
|
| Secondary | Number of Days to Reach Therapeutic Trough Goal | Days to reach therapeutic goal after conversion | Days to reach therapeutic goal was further separated by CYP3A5 1 expression. | Posted | Median | Inter-Quartile Range | number of days | Baseline to 3 months post conversion |
|
|
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| Secondary | Dose Modifications | Number of dose modifications from baseline to 3 months post-conversion. | 12 participants are homozygous, 10 are heterozygous, and 3 are non-expressors. This represents the 25 total subjects in the study. | Posted | Median | Inter-Quartile Range | number of dose modifications | Baseline to 3 months post conversion |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 19 |
| 25 |
| Pain | General disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin infection (abscess) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Muscle Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chronic myeloid leukemia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
|
| CYP3A5 1 non-expressors |
|
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| CYP3A5 1 non expressers |
|
|